orlistat and Diabetes-Mellitus

orlistat has been researched along with Diabetes-Mellitus* in 35 studies

Reviews

9 review(s) available for orlistat and Diabetes-Mellitus

ArticleYear
Molecular exploration of combinational therapy of orlistat with metformin prevents the COVID-19 consequences in obese diabetic patients.
    European review for medical and pharmacological sciences, 2021, Volume: 25, Issue:2

    Topics: Anti-Obesity Agents; COVID-19; Diabetes Mellitus; Drug Therapy, Combination; Humans; Hypoglycemic Agents; Metformin; Obesity; Orlistat

2021
Obesity and diabetes.
    Handbook of experimental pharmacology, 2012, Issue:214

    Topics: Animals; Cyclobutanes; Diabetes Mellitus; Female; Humans; Incretins; Insulin; Lactones; Male; Metformin; Obesity; Orlistat; Piperidines; Pyrazoles; Rimonabant; Sex Characteristics; Sulfonylurea Compounds

2012
Use of lifestyle changes treatment plans and drug therapy in controlling cardiovascular and metabolic risk factors.
    Obesity (Silver Spring, Md.), 2006, Volume: 14 Suppl 3

    Intervention in weight management should begin before the onset of the metabolic syndrome. Therapeutic lifestyle changes (e.g., diet and physical activity) comprise the cornerstone of care for overweight and obese patients. Behavior modification approaches are useful in facilitating adherence to specific dietary regimens. Pharmacotherapy is an option for patients with a BMI >30 kg/m(2) or for those with a BMI of 27 to 30 kg/m(2) and two or more risk factors, who have failed on diet and exercise alone. To date, the U.S. Food and Drug Administration has approved three weight loss agents: sibutramine, orlistat, and phentermine.

    Topics: Caloric Restriction; Cardiovascular Diseases; Cyclobutanes; Diabetes Mellitus; Diet; Diet, Fat-Restricted; Diet, Mediterranean; Exercise; Feeding Behavior; Food, Formulated; Humans; Lactones; Metabolic Syndrome; Obesity; Orlistat; Phentermine; Prediabetic State; Risk Reduction Behavior; Weight Loss

2006
A systematic review of the clinical effectiveness of orlistat used for the management of obesity.
    Obesity reviews : an official journal of the International Association for the Study of Obesity, 2004, Volume: 5, Issue:1

    The aim of this paper is to assess the clinical effectiveness of orlistat used for the management of obesity. Nineteen electronic databases were searched for randomized controlled trials evaluating the effectiveness of orlistat for weight loss or maintenance of weight loss in overweight or obese patients. Each included trial was assessed for methodological quality. Statistical pooling was performed when trials were considered to be sufficiently similar. Twenty-three trials were eligible for inclusion. Placebo-controlled trials recruiting patients with uncomplicated obesity reported statistically significant differences in favour of orlistat for weight loss and changes in obesity-related risk factors at all time points. Trials in obese patients with defined risk factors at baseline showed similar results, however, smaller effect sizes were observed in patients with type 2 diabetes. The effectiveness of orlistat relative to other anti-obesity drugs is currently unclear. When orlistat was added to simvastatin, this proved to be more effective for weight loss than either drug used individually. Orlistat use is associated with a higher incidence of gastrointestinal adverse events compared with placebo. In conclusion, orlistat is more effective than placebo in promoting weight loss, maintenance of weight loss, and improving cardiovascular risk factor profiles. Baseline parameters of patients seen in clinical practice should be taken into account when considering treatment.

    Topics: Anti-Obesity Agents; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Humans; Hyperlipidemias; Lactones; Obesity; Orlistat; Placebos; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome; Weight Loss

2004
[Pharmacotherapy of obesity].
    Wiener medizinische Wochenschrift (1946), 2004, Volume: 154, Issue:13-14

    Obesity is a chronic disease with a worldwide increasing incidence. The mainstay of therapy consists in modification of behaviour related to obesity such as overeating and physical inactivity. When these life-style modifying attempts fail, the use of anti-obesity drugs is warranted. The two available drugs, orlistat and sibutramine, are capable of reducing body weight by 10%. Failure of these medications in a subset of patients to achieve adequate weight loss and limited overall efficacy have led to an extensive research on novel anti-obesity agents. This review presents an overview on the current drugs available as well as on potential future candidates.

    Topics: Appetite Depressants; Body Weight; Clinical Trials as Topic; Cyclobutanes; Diabetes Mellitus; Humans; Lactones; Obesity; Orlistat; Satiety Response; Treatment Outcome

2004
[Obesity in patients with diabetes].
    Nihon rinsho. Japanese journal of clinical medicine, 2002, Volume: 60 Suppl 10

    Topics: Adrenergic Agonists; Anti-Obesity Agents; Behavior Therapy; Diabetes Mellitus; Diet, Reducing; Enzyme Inhibitors; Exercise Therapy; Gastric Bypass; Humans; Hypoglycemic Agents; Lactones; Lipase; Obesity; Orlistat; Serotonin Receptor Agonists

2002
New antiobesity agents in type 2 diabetes: overview of clinical trials with sibutramine and orlistat.
    Diabetes & metabolism, 2002, Volume: 28, Issue:6 Pt 1

    Besides genetic predisposition, obesity is the most important risk factor for the development of type 2 diabetes mellitus. Even modest weight reduction can improve blood glucose control in overweight subjects. After failure of lifestyle modifications, antiobesity drugs such as orlistat, a potent and selective inhibitor of gastric and pancreatic lipases that reduces lipid intestinal absorption, or sibutramine, a noradrenaline and 5-hydroxytryptamine reuptake inhibitor that regulates food intake, may be considered to favour weight loss and/or weight maintenance. Several placebo-controlled studies have recently demonstrated that both drugs are able to promote weight loss in obese type 2 diabetic patients treated with diet alone, sulphonylureas, metformin or insulin. The greater weight reduction as compared to placebo was associated with a significant reduction of glycated haemoglobin levels and/or of the doses of classical antihyperglycaemic agents, especially in good responders who lost at least 10% of initial body weight. In addition, vascular risk factors associated to insulin resistance were also reduced after weight loss. These antiobesity agents may also contribute to delay or prevent the progression from impaired glucose tolerance to overt type 2 diabetes in at risk obese individuals ("Xenical in the prevention of diabetes in obese subjects" trial). Large long-term prospective studies, such as the "Sibutramine cardiovascular and diabetes outcome study" should better determine the place of pharmacological anti-obesity strategy in the overall management of obese patients with impaired glucose tolerance or type 2 diabetes.

    Topics: Anti-Obesity Agents; Appetite Depressants; Blood Glucose; Clinical Trials as Topic; Controlled Clinical Trials as Topic; Cyclobutanes; Diabetes Mellitus; Diabetes Mellitus, Type 2; Humans; Lactones; Obesity; Orlistat; Weight Loss

2002
Obesity and type 2 diabetes: a conflict of interests?
    International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity, 1999, Volume: 23 Suppl 7

    Obesity is a major risk factor for the development of type 2 diabetes and is an important obstacle to the management of this disease. The increasing incidence of both obesity and type 2 diabetes makes management of these related conditions particularly important. Conventional approaches to the management of type 2 diabetes that focus primarily on improving glycaemic control-notably insulin or sulphonylurea treatment-often lead to weight gain, which is particularly detrimental to patients with type 2 diabetes. By contrast, reducing body weight in such patients improves glycaemic control and other cardiovascular risk factors associated with the metabolic syndrome. This suggests that weight reduction is a rational option in the management of obese patients with type 2 diabetes. While reductions in body weight of approximately 10% have been achieved in some studies, this is difficult to achieve in real life, especially for patients with type 2 diabetes. Weight management agents such as sibutramine and orlistat, used as part of an integrated programme of diet, physical activity and behavioural therapy, are thus an attractive early option for the management of type 2 diabetes in obese patients.

    Topics: Anti-Obesity Agents; Appetite Depressants; Cyclobutanes; Diabetes Complications; Diabetes Mellitus; Diabetes Mellitus, Type 2; Humans; Lactones; Obesity; Orlistat; Weight Loss

1999
Obesity medications and the treatment of type 2 diabetes.
    Diabetes technology & therapeutics, 1999,Fall, Volume: 1, Issue:3

    Obesity is a chronic disease and requires ongoing treatment. Type 2 diabetes is associated with obesity and improves with weight loss. Diets of 800 kcal/d induce twice the weight loss induced by weight loss medications. The strength of weight loss medication, which should be used with diet and a lifestyle change program, is the maintenance of weight loss. Sibutramine and orlistat are the only two medications approved for the long-term treatment of obesity. Orlistat gives a reduction of low-density lipoprotein (LDL) cholesterol in excess of that expected with weight loss, and the drop in blood pressure expected with weight loss is not seen with sibutramine. Except in newly diagnosed patients with diabetes subjects, patients with diabetes lose half the weight of subjects who do not have diabetes when treated with weight loss medications. Metformin and, to a lesser extent, acarbose cause weight loss, making them attractive choices for the treatment of obese type 2 diabetic subjects. Repaglinide appears to be weight-neutral, but other medications for patients with diabetes can be associated with weight gain. Many new medications are in development for the treatment of obesity. These new medications act through a variety of mechanisms and will surely play an increasingly important role in the treatment of obese patients with type 2 diabetes.

    Topics: Acarbose; Anti-Obesity Agents; Appetite Depressants; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diet, Reducing; Humans; Hypoglycemic Agents; Lactones; Life Style; Metformin; Obesity; Orlistat; Weight Loss

1999

Trials

14 trial(s) available for orlistat and Diabetes-Mellitus

ArticleYear
The effect of single-dose orlistat on postprandial serum glucose, insulin and glucagon-like peptide-1 levels in nondiabetic obese patients.
    Clinical endocrinology, 2007, Volume: 67, Issue:3

    Glucagon-like peptide-1 is an insulin secretion-stimulating gut hormone that is produced in response to food intake. Orlistat (Xenical, F. Hoffman-La Roche, Basel, Switzerland), which decreases fat absorption and increases intestinal fat content, may therefore affect the secretion of glucagon-like peptide-1. In this study we examined the immediate effects of orlistat on postprandial serum glucose, insulin and glucagon-like peptide-1 levels prior to a change in body weight.. Randomized, clinical study.. Sixteen nondiabetic obese patients (body mass index 35.7 +/- 3.8 kg/m(2), range 32.5-43.1) were enrolled in this study. The patients were randomly assigned to either the group treated with orlistat (120 mg, single dose) or the control group. There were eight patients in each of the two groups. Orlistat was given before a standard 600-kcal mixed meal containing 60% carbohydrates, 25% lipids and 15% protein. Blood samples were collected at baseline and at 30-min intervals for 180 min after the test meal. Graphical tendencies, peak value, time to reach the peak value, and area under the curve in the two groups were compared.. Blood samples were obtained for the measurement of GLP-1, glucose, insulin, high density lipoprotein, total cholesterol and triglycerides.. We found no difference in sex distribution, mean age, anthropometric measurements, or baseline glucose, insulin and glucagon-like peptide-1 levels between the orlistat and placebo groups. The peak insulin and glucagon-like peptide-1 levels were determined at 60 min in the control group. Hourly changes in serum glucose and insulin levels were similar between the groups, although the peak insulin and glucagon-like peptide-1 levels were reached at 120 min in the orlistat group. There were no statistically significant differences between the groups.. A single dose of 120-mg orlistat caused no change in postprandial serum glucose, insulin or glucagon-like peptide-1 levels in nondiabetic obese patients. Although glucagon-like peptide-1 increases were delayed in the orlistat group, these changes were nonsignificant.

    Topics: Adult; Anti-Obesity Agents; Blood Glucose; Diabetes Mellitus; Female; Glucagon-Like Peptide 1; Humans; Hyperglycemia; Insulin; Lactones; Male; Middle Aged; Obesity; Orlistat

2007
Orlistat for obesity: benefits beyond weight loss.
    Diabetes research and clinical practice, 2005, Volume: 67, Issue:1

    Orlistat lowers lipids and improves insulin sensitivity, but its effect on other metabolic syndrome related parameters is not known. To assess its influence on adiponectin, high sensitive C-reactive protein (hs-CRP) and other metabolic syndrome related parameters, this study enrolled 106 participants in a weight-reduction program and categorized them into a group of 51 who had been treated with orlistat 360 mg/day for one year and a group of 55 age and sex and body mass index (BMI) matched controls. The orlistat group had greater changes in BMI, % body fat (% BF), waist circumference, and insulin resistance, hs-CRP, leptin and adiponectin levels after one year on the program than the controls. After adjusting for % BF and waist circumference, change of serum leptin and adiponectin levels remained significantly different. It was found that orlistat could effectively manage obesity related co-morbidities, especially insulin resistance and atherosclerosis risk. It decreases leptin and increases adiponectin independent of % BF and waist circumference. Therefore, orlistat appears to have anti-diabetic and anti-atherogenic properties and may help prevent metabolic syndrome in the overweight people.

    Topics: Adult; Anti-Obesity Agents; Arteriosclerosis; Blood Glucose; Body Mass Index; C-Reactive Protein; Cholesterol; Diabetes Mellitus; Female; Humans; Hypoglycemic Agents; Lactones; Lipoproteins; Male; Middle Aged; Obesity; Orlistat; Weight Loss

2005
Effects of moderate weight loss and orlistat on insulin resistance, regional adiposity, and fatty acids in type 2 diabetes.
    Diabetes care, 2004, Volume: 27, Issue:1

    Moderate weight loss is recommended for overweight and obese patients with type 2 diabetes, and conjunctive use of weight loss medication has been advocated. The current study examined weight loss-dependent and -independent effects of the intestinal lipase inhibitor orlistat at 6 months of treatment, using behavioral intervention (Int) combined with randomized, double-blinded, placebo (P)-controlled treatment with orlistat (O).. Metabolic control, insulin sensitivity (IS), regional fat distribution, and fat content in liver and muscle were measured in 39 volunteers with type 2 diabetes in whom all antidiabetic medication was withdrawn 1 month preceding randomization. Weight loss was equivalent in the Int+O and Int+P groups, respectively (-10.3 +/- 1.3 vs. -8.9 +/- 1.1%), and there were identical decreases in visceral adipose tissue (VAT), fat mass (FM), thigh adiposity, and hepatic steatosis.. Weight loss resulted in substantial improvement (P < 0.001) in HbA(1c) (-1.6 +/- 0.3 vs. -1.0 +/- 0.4%; NS between groups). IS improved significantly more with orlistat (Delta2.2 +/- 0.4 vs. Delta1.2 +/- 0.4 mg. min(-1). kg(-1) fat-free mass [FFM]; P < 0.05), and plasma free fatty acid (FFA) levels were strongly correlated with IS (r = 0.56; P < 0.001). Orlistat caused greater reductions in fasting plasma FFA (Delta-154 +/- 22 vs. Delta-51 +/- 33 micro mol/l; P < 0.05), insulin-suppressed FFA (Delta-119 +/- 23 vs. Delta-87 +/- 34 micro mol/l; P < 0.05), and fasting plasma glucose (FPG; -62 +/- 9 vs. -32 +/- 8 mg/dl; P = 0.02). Changes in HbA(1c) were correlated with DeltaIS (r = -0.41; P < 0.01) but not with weight loss per se.. At equivalent weight loss, conjunctive use of orlistat resulted in greater improvement in FFA levels and IS.

    Topics: Adipose Tissue; Blood Glucose; Body Composition; Body Mass Index; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind Method; Glucose; Humans; Hypoglycemic Agents; Insulin Resistance; Lactones; Obesity; Orlistat; Placebos; Time Factors; Weight Loss

2004
XENical in the prevention of diabetes in obese subjects (XENDOS) study: a randomized study of orlistat as an adjunct to lifestyle changes for the prevention of type 2 diabetes in obese patients.
    Diabetes care, 2004, Volume: 27, Issue:1

    It is well established that the risk of developing type 2 diabetes is closely linked to the presence and duration of overweight and obesity. A reduction in the incidence of type 2 diabetes with lifestyle changes has previously been demonstrated. We hypothesized that adding a weight-reducing agent to lifestyle changes may lead to an even greater decrease in body weight, and thus the incidence of type 2 diabetes, in obese patients.. In a 4-year, double-blind, prospective study, we randomized 3,305 patients to lifestyle changes plus either orlistat 120 mg or placebo, three times daily. Participants had a BMI >/=30 kg/m2 and normal (79%) or impaired (21%) glucose tolerance (IGT). Primary endpoints were time to onset of type 2 diabetes and change in body weight. Analyses were by intention to treat.. Of orlistat-treated patients, 52% completed treatment compared with 34% of placebo recipients (P < 0.0001). After 4 years' treatment, the cumulative incidence of diabetes was 9.0% with placebo and 6.2% with orlistat, corresponding to a risk reduction of 37.3% (P = 0.0032). Exploratory analyses indicated that the preventive effect was explained by the difference in subjects with IGT. Mean weight loss after 4 years was significantly greater with orlistat (5.8 vs. 3.0 kg with placebo; P < 0.001) and similar between orlistat recipients with impaired (5.7 kg) or normal glucose tolerance (NGT) (5.8 kg) at baseline. A second analysis in which the baseline weights of subjects who dropped out of the study was carried forward also demonstrated greater weight loss in the orlistat group (3.6 vs. 1.4 kg; P < 0.001).. Compared with lifestyle changes alone, orlistat plus lifestyle changes resulted in a greater reduction in the incidence of type 2 diabetes over 4 years and produced greater weight loss in a clinically representative obese population. Difference in diabetes incidence was detectable only in the IGT subgroup; weight loss was similar in subjects with IGT or NGT [correction].

    Topics: Adult; Body Mass Index; Diabetes Mellitus; Double-Blind Method; Energy Intake; Female; Glucose Tolerance Test; Humans; Lactones; Life Style; Lipase; Male; Middle Aged; Obesity; Orlistat; Placebos; Prospective Studies

2004
Orlistat augments postprandial increases in glucagon-like peptide 1 in obese type 2 diabetic patients.
    Diabetes care, 2004, Volume: 27, Issue:5

    Orlistat leads to improved glycemic control in obese type 2 diabetic patients, which is attributed to decreased insulin resistance associated with weight loss. Glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) are gut hormones that are secreted in response to food intake, and they both stimulate insulin secretion. Orlistat decreases fat absorption and increases intestinal fat content, which may lead to increased secretion of these peptides. In this pilot study, we tested the hypothesis that increased levels of these intestinal hormones may be involved in the improvement of postprandial hyperglycemia observed previously with orlistat in type 2 diabetic patients.. A total of 29 type 2 diabetic patients, who were not taking insulin or alpha-glucosidase inhibitors, were enrolled in the study. On a crossover and single-blind design, after an overnight fasting, the patients received 120-mg orlistat or placebo capsules, followed by a standard 600-kcal mixed meal that contained 38% fat. At baseline and 60 min after the meal, blood samples were obtained for the measurement of GLP-1, GIP, insulin, C-peptide, triglycerides, free fatty acids, and glucose.. All measured parameters increased significantly in response to the mixed meal compared with baseline, both with orlistat or placebo. When compared with the placebo, the orlistat administration resulted in a significantly enhanced postprandial increase in GLP-1 and C-peptide levels and attenuated the postprandial rise in glucose and triglycerides.. The results of this study suggest that apart from decreasing insulin resistance as a result of weight loss, orlistat may increase postprandial GLP-1 levels, thereby enhancing the insulin secretory response to the meal and blunting the postprandial rise in glucose in type 2 diabetic patients. Increased GLP-1 levels, which lead to decreased food intake, may also contribute to the weight loss that is associated with the use of this drug.

    Topics: Adult; Aged; Anti-Obesity Agents; Cross-Over Studies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Female; Gastric Inhibitory Polypeptide; Glucagon; Glucagon-Like Peptide 1; Humans; Insulin; Lactones; Male; Middle Aged; Obesity; Orlistat; Peptide Fragments; Protein Precursors; Single-Blind Method; Weight Loss

2004
Orlistat as an adjunct therapy in type 2 obese diabetic patients treated with sulphonylurea: a Bangladesh experience.
    Bangladesh Medical Research Council bulletin, 2004, Volume: 30, Issue:1

    Co-existence of obesity and type 2 DM exacerbates metabolic and other remediable health consequences further. Various pharmacological therapies have been adopted when changing of lifestyle fail to achieve target glycaemic control. Our objective is to find out whether Orlistat can reduce both weight and need for oral hypoglycaemic agent (OHA) and improves glycaemic status,lipid disorders, blood pressure in Bangladesh type 2 DM with obesity. In this center, open-label, randomized, controlled pilot trial 36 type 2 patients with obesity were enrolled. All patients aged 40-65 years had BMI >25 kg/m2 taking sulfonylureas and hypocalorie diet. Twenty one randomly cases were treated with orlistat 120 mg three times daily for 6 months and 15 without orlistat as control. Body weight, waist circumferances, fasting blood sugar, HbAlc,serum lipids, blood pressure and dose of drugs were monitored at 0,12, 24 weeks. After 6 months, orlistat group showed non-significant weight loss than control group (3.95% vs 1.42% from base lines), but showed significant reduction of waist circumference (6 % vs 0.63 %, p<0.01 vs p>0.05 from base line). Orlistat group had significant improvement in glycaemic status (HbA1c changes: 22.37% vs 13.38%, p<0.001 vs p>0.05 and FBS changes: 21.76% vs 22.95%, p<0.01vs p<0.05). Lipid profile had reduced significantly from base lines (Chol: 19.31% vs 9.12%,p<0.001vs >0.05; LDL Chol: 24.99% vs 19.09%, p<0.001 vs p<0.01; Triglyceride: 34.48% vs 12.61%, p<0.001 vs p>0.05). Diastolic pressure had improved significantly in orlistat group (6.73% vs 3.70%, p<0.01 vs >0.05). Reduction of OHA doses were found in both groups. Thus orlistat can be used as an adjuvant therapy with other OHA in managing glycaemic control, lipid profiles and blood pressure.

    Topics: Adult; Aged; Bangladesh; Case-Control Studies; Chemotherapy, Adjuvant; Diabetes Mellitus; Diabetes Mellitus, Type 2; Humans; Lactones; Lipase; Middle Aged; Obesity; Orlistat; Sulfonylurea Compounds; Treatment Outcome

2004
Latin-American trial of orlistat for weight loss and improvement in glycaemic profile in obese diabetic patients.
    Diabetes, obesity & metabolism, 2003, Volume: 5, Issue:3

    To determine if obese non-insulin-dependent diabetic patients lose more weight when treated for 24 weeks (6 months) with orlistat (120 mg t.i.d.), in conjunction with a hypocaloric diet plus behavioural counselling, than when treated by placebo (t.i.d.) plus similar instructions. The secondary objectives were to evaluate the effects on glucose profile and to determine the tolerability and safety of orlistat.. Double-blind, parallel, randomized, placebo-controlled, multicentre study.. Obese, non-insulin-dependent diabetic patients, aged 18-70 years old, with BMI > 27 kg/m2, evaluated at 10 Latin-American centres, in five countries. EFFICACY AND TOLERABILITY MEASUREMENTS: After screened, eligible patients passed by a 2-week placebo run-in period receiving a hypocaloric diet. On day 0, patients were randomized to orlistat or placebo for 24 weeks. At each visit, body weight, blood pressure and waist circumference were measured. At the screening visit, baseline visit (week 0), and at weeks 8, 16 and 24, a central laboratory was in charge of measuring fasting glucose and insulin, HbA1c, postprandial glucose and insulin, fasting total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, and postprandial triglycerides. Other safety laboratory assessments were measured locally at the screening visit, baseline visit and at the end of the study. Adverse events were assessed at each visit from baseline.. After 24 weeks of treatment, the orlistat group lost an average of 4.7% of initial body weight vs. 3.0% in the placebo group (p = 0.0003). A greater weight loss was achieved in the orlistat compared with the placebo group (4.24 +/- 0.23 vs. 2.58 +/- 1.46 kg, p = 0.0003). Almost twice as many patients receiving orlistat (30% vs. 17%) lost > or = 5% of initial body weight (p = 0.003). Orlistat treatment plus diet compared to placebo plus diet was associated with significant improvement in glycaemic control, as reflected in decreases in HbA1c (p = 0.04), fasting plasma glucose (p = 0.036) and postprandial glucose (p = 0.05). Orlistat-treated patients had a mean decrease in glucose levels of 1.00 +/- 0.34 mmol/l [3.7%] vs. 0.01 +/- 0.30 mmol/l for placebo group, at week 24 and an absolute decrease of HbA1c of 0.61 +/- 0.15 vs. a decrease of 0.22 +/- 0.14% in the placebo group. Orlistat therapy also resulted in significantly greater improvements than placebo in lipid profile, with reductions in total cholesterol (p = 0.0001) and LDL-cholesterol (p = 0.002). Mild to moderate transient gastrointestinal events were reported, mainly with orlistat treatment, but their association with withdrawal from the study was low.. Orlistat is a useful and an effective therapy in obese diabetic patients, promoting clinically significant weight loss and improved glycaemic control and lipid profile.

    Topics: Adolescent; Adult; Aged; Anthropometry; Anti-Obesity Agents; Blood Glucose; Blood Pressure; Combined Modality Therapy; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diet, Reducing; Double-Blind Method; Enzyme Inhibitors; Female; Glycated Hemoglobin; Humans; Insulin; Lactones; Lipase; Lipids; Male; Middle Aged; Obesity; Orlistat; Risk Factors; Weight Loss

2003
Orlistat in hypertensive overweight/obese patients: results of a randomized clinical trial.
    Journal of hypertension, 2003, Volume: 21, Issue:11

    To assess the effect of orlistat plus diet compared with diet alone in promoting weight loss and blood pressure reduction in hypertensive, overweight/obese patients.. A pragmatic randomized, controlled trial.. Hypertension clinic of a university hospital.. Hypertensive patients aged 18-75 years with a body mass index greater than 25 kg/m(2).. Orlistat 360 mg/day combined with a hypocaloric diet (treatment group), or a calorie-restricted diet alone (control group).. Primary outcomes were reductions in weight and blood pressure. Secondary outcomes were decreases in lipid and glucose concentrations. A subgroup analysis of the main outcomes among diabetic and non-diabetic patients was also performed.. A total of 204 patients were included in the intention-to-treat analysis. After 12 weeks the orlistat group lost, on average, 3.7 kg and the control group lost 2.0 kg in weight (P < 0.001). Systolic (SBP) and diastolic (DBP) blood pressures decreased by 15.3 and 11.4 mmHg, respectively, in the group given orlistat plus a hypocaloric diet and by 11.6 and 5.2 mmHg, respectively, in the control group given the calorie-restricted diet alone (P = 0.25 and P = 0.0004, respectively). Fasting glucose (0.82 and 0.17 mmol/l, P = 0.01) and total cholesterol (0.85 and 0.56 mmol/l, P = 0.05) were reduced to a greater extent with orlistat than with diet alone. The mean reduction in triglycerides with orlistat plus the hypocaloric diet was 0.75 mmol/l and that in the control group was 0.30 mmol/l (P = 0.28); the increases in high-density lipoprotein cholesterol were 0.05 and 0.00 mmol/l, respectively, in the two groups (P = 0.17). Treatment improved blood pressure and glucose control in the individuals with diabetes, but not in those without diabetes.. In both groups there was a reduction in weight, blood pressure and metabolic parameters. The orlistat group performed better in reducing weight, DBP, glucose and cholesterol. Results show that even a small reduction in weight helps to control blood pressure and glucose. The cost-benefit of the use of orlistat should be evaluated for hypertensive obese patients.

    Topics: Aged; Anti-Obesity Agents; Blood Glucose; Blood Pressure; Body Mass Index; Caloric Restriction; Cholesterol; Diabetes Complications; Diabetes Mellitus; Diastole; Fasting; Female; Humans; Hypertension; Lactones; Lipids; Male; Middle Aged; Obesity; Orlistat; Systole; Weight Loss

2003
The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial.
    Diabetes, obesity & metabolism, 2002, Volume: 4, Issue:6

    To assess the long-term effects of orlistat on body weight, glycaemic control and cardiovascular risk factors in overweight patients with type 2 diabetes.. This was a multicentre, randomized, placebo-controlled study with a 4-week placebo plus diet lead-in period and a 48-week, double-blind treatment period. Overweight or obese adults [body mass index (BMI) >or= 28 kg/m2] with HbA1c of 6.5-11% and clinical type 2 diabetes were randomized to orlistat (120 mg t.i.d. n = 189) or placebo (n = 180) in conjunction with a low-calorie diet. Patients had either received sulphonylurea therapy for at least 2 months before the study or were not receiving any antidiabetic medication (the majority of which were drug-naïve).. After 1 year, patients in the orlistat group lost significantly more weight than patients in the placebo group (-5.4% vs. -3.6%; p = 0.006). Moreover, significantly more patients achieved weight loss of >or= 5% with orlistat compared with placebo (51.3% vs. 31.6%; p = 0.0001). Patients treated with orlistat also had significantly greater improvements than placebo-treated patients in HbA1c (-0.9% vs. -0.4%; p < 0.001), fasting glucose (-1.6 vs.-0.7 mmol/l; p = 0.004) and post-prandial glucose (-1.8 vs. -0.5 mmol/l; p = 0.003). In addition, orlistat-treated patients had a significantly greater reduction in LDL cholesterol compared with placebo. Overall, orlistat had a similar safety profile to placebo, with the exception of a higher incidence of generally mild and transient gastrointestinal events known to be associated with the mode of action of orlistat.. Treatment with orlistat plus diet resulted in significant weight loss, improved glycaemic control and cardiovascular risk factor profile in overweight patients with type 2 diabetes.

    Topics: Adolescent; Adult; Aged; Anti-Obesity Agents; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diet, Reducing; Double-Blind Method; Female; Glycated Hemoglobin; Humans; Lactones; Male; Middle Aged; Obesity; Orlistat; Risk Factors

2002
Acute effect of orlistat on post-prandial lipaemia and free fatty acids in overweight patients with Type 2 diabetes mellitus.
    Diabetic medicine : a journal of the British Diabetic Association, 2002, Volume: 19, Issue:11

    Post-prandial lipaemia is prolonged and exaggerated in patients with Type 2 diabetes mellitus, with an accumulation of atherogenic triglyceride-rich lipoprotein remnants. We postulate that orlistat, a gastrointestinal lipase inhibitor, may cause changes in post-prandial lipoprotein metabolism by reducing dietary triglyceride absorption.. The acute effect of a single dose of 120 mg orlistat on post-prandial glucose, lipids, remnant lipoproteins and free fatty acids (FFA) was evaluated in a randomized, double-blind, placebo-controlled cross-over study of 63 overweight patients with Type 2 diabetes mellitus (body mass index 30.4 +/- 3.8 kg/m2). Either a single dose of orlistat or placebo was given before a standard mixed meal containing 70 g of fat and plasma triglyceride (TG), remnant-like particles cholesterol (RLP-C) and FFA were sampled at 2-h intervals for 8 h. RLP-C was measured by an immunoseparation assay and FFA by an enzymatic colorimetric method.. The concentrations of plasma TG (P < 0.0001), RLP-C (P = 0.003), and FFA (P < 0.0001) were significantly lower at 2 h after orlistat compared with placebo. Both plasma RLP-C (P = 0.04) and FFA (P < 0.0001) remained lower after orlistat than placebo at 4 h. The incremental area under the curve (iAUC) above baseline fasting level for both TG and RLP-C was significantly more reduced after orlistat than placebo (iAUC-TG 5.8 (3.7-8.2) mmol/l x h-1 vs. 5.7 (4.1-10.9), respectively, P = 0.04; iAUC-RLP-C: 0.53 (0.23-1.04) mmol/l x h-1 vs. 0.56 (0.35-1.40), respectively, P = 0.02). The test meal was well tolerated by all subjects, with only three subjects reporting faecal urgency after orlistat.. Orlistat has a beneficial effect on post-prandial lipaemia in overweight Type 2 diabetic patients and lowers plasma TG, RLP-C and FFA in the early post-prandial period.

    Topics: Adult; Anti-Obesity Agents; Cholesterol; Cross-Over Studies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dietary Fats; Double-Blind Method; Enzyme Inhibitors; Fatty Acids, Nonesterified; Female; Humans; Hyperlipidemias; Lactones; Lipase; Lipoproteins; Male; Middle Aged; Obesity; Orlistat; Postprandial Period; Triglycerides

2002
Evaluation of the safety and efficacy of sibutramine, orlistat and metformin in the treatment of obesity.
    Diabetes, obesity & metabolism, 2002, Volume: 4, Issue:1

    Some of our obese patients who were receiving 10 mg/day sibutramine reported feeling hunger at night. To address this, we designed a randomized, prospective clinical trial to study the efficacy and safety of 10 mg sibutramine twice daily (bid), and compare this treatment with 120 mg orlistat three times daily (tid) and 850 mg metformin (bid).. A total of 150 female patients with body mass index (b.m.i.) > 30 kg/m(2) were included. The subjects were all out-patients at the Başkent University Endocrinology and Metabolism Clinic. Each individual was assigned randomly to receive 10 mg sibutramine bid (group 1; n = 50; mean age 42.27 +/- 1.40 years), 120 mg orlistat tid (group 2; n = 50; mean age 42.13 +/- 1.32 years) or 850 mg metformin bid (group 3; n = 50; mean age 43.58 +/- 1.40 years). All patients took the medications for 6 months. Two patients from the sibutramine group and two from the orlistat group were withdrawn from the study because of side-effects.. After 6 months of treatment, the sibutramine, orlistat, and metformin groups all showed significantly reduced b.m.i. (13.57%, 9.06% and 9.90% respectively); waist circumference (10.43%, 6.64%, and 8.10% respectively); fasting and postprandial blood glucose levels; insulin resistance as assessed by the homeostasis model for assessment of insulin resistance (HOMA) (38.63%, 32.73% and 39.28%, respectively); levels of total cholesterol, low-density lipoprotein (LDLC) cholesterol, very low-density lipoprotein (VLDLC) cholesterol, triglyceride, lipoprotein (a), and apolipoprotein B; uric acid level; pulse rate; and systolic and diastolic blood pressure. None of the groups showed any significant changes in levels of high-density lipoprotein (HDLC) cholesterol, or apolipoprotein A1. There was a significantly greater fall in b.m.i. in the sibutramine group than in either of the other groups (p < 0.0001).. The results of this study confirm that sibutramine, orlistat and metformin are all effective and safe medications that reduce cardiovascular risk and can decrease the risk of type 2 diabetes mellitus in obese females. Overall, treatment with 10 mg sibutramine bid is more effective than orlistat or metformin therapy in terms of weight reduction.

    Topics: Adult; Anti-Obesity Agents; Appetite Depressants; Blood Glucose; Body Mass Index; Body Weight; Cyclobutanes; Diabetes Mellitus; Female; Humans; Hypoglycemic Agents; Lactones; Metformin; Obesity; Orlistat; Postprandial Period; Safety; Treatment Outcome; Weight Loss

2002
Clinical efficacy of orlistat therapy in overweight and obese patients with insulin-treated type 2 diabetes: A 1-year randomized controlled trial.
    Diabetes care, 2002, Volume: 25, Issue:6

    OBJECTIVE; Weight loss improves glycemic control, lipid profiles, and blood pressure in patients with type 2 diabetes. However, successful long-term weight loss is difficult for these patients, particularly those treated with insulin. The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on weight loss, glycemic control, and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients.. This study was a 1-year multicenter, randomized, double-blind, placebo-controlled trial of orlistat (120 mg three times a day) or placebo combined with a reduced-calorie diet in overweight or obese adults (BMI 28-40 kg/m(2)) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA(1c) 7.5-12.0%). Outcome measurements included changes in body weight, glycemic control, blood pressure, and serum lipids. RESULTS; After 1 year, the orlistat group lost significantly more weight (-3.89 +/- 0.3% of baseline body weight, means +/- SE) than the placebo group (-1.27 +/- 0.3%, P < 0.001). Orlistat treatment, compared with placebo, produced greater decreases in HbA(1c) (-0.62 +/- 0.08 vs. -0.27 +/- 0.08%, P = 0.002), fasting serum glucose (-1.63 +/- 0.3 vs. -1.08 +/- 0.3 mmol/l, P = 0.02), and the required doses of insulin and other diabetic medications. Orlistat also produced greater improvements than placebo in serum total cholesterol (P = 0.0002) and LDL cholesterol concentrations (P = 0.001) and LDL/HDL ratio (P = 0.01). CONCLUSIONS; Orlistat therapy produces clinically significant weight loss, with improvements in glycemic control and cardiovascular disease risk factors, in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy.

    Topics: Anti-Obesity Agents; Blood Glucose; Body Mass Index; Body Weight; Diabetes Mellitus; Diabetes Mellitus, Type 2; Double-Blind Method; Fasting; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Insulin; Lactones; Male; Middle Aged; Obesity; Orlistat; Patient Dropouts; Placebos; Racial Groups; Time Factors; Weight Loss

2002
Effect of orlistat in overweight and obese patients with type 2 diabetes treated with metformin.
    Diabetes care, 2002, Volume: 25, Issue:7

    The purpose of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on body weight, glycemic control, and cardiovascular risk factors in metformin-treated type 2 diabetic patients.. A 1-year multicenter, randomized, double-blind, placebo-controlled trial of 120 mg orlistat t.i.d. (n = 249) or placebo (n = 254) combined with a reduced-calorie diet was conducted in overweight and obese patients with suboptimal control of type 2 diabetes.. After 1 year of treatment, mean (+/-SE) weight loss was greater in the orlistat than in the placebo group (-4.6 +/- 0.3% vs. -1.7 +/- 0.3% of baseline wt, P < 0.001). Orlistat treatment caused a greater improvement in glycemic control than placebo, as evidenced by a greater reduction in serum HbA(1c), adjusted for changes in metformin and sulfonylurea therapy (-0.90 +/- 0.08 vs. -0.61 +/- 0.08, P = 0.014); a greater proportion of patients achieving decreases in HbA(1c) of > or = 0.5 and > or = 1.0% (both P < 0.01); and a greater reduction in fasting serum glucose (-2.0 +/- 0.2 vs. -0.7 +/- 0.2 mmol/l, P = 0.001). Compared with the placebo group, patients treated with orlistat also had greater decreases in total cholesterol, LDL cholesterol, and systolic blood pressure (all P < 0.05). Although more subjects treated with orlistat experienced gastrointestinal side effects than placebo (83 vs. 62%, P < 0.05), more subjects in the placebo group withdrew prematurely from the study than in the orlistat group (44 vs. 35%, P < 0.05).. Orlistat is a useful adjunctive treatment for producing weight loss and improving glycemic control, serum lipid levels, and blood pressure in obese patients with type 2 diabetes who are being treated with metformin.

    Topics: Adult; Aged; Anti-Obesity Agents; Blood Glucose; Blood Pressure; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diet, Reducing; Double-Blind Method; Humans; Hypoglycemic Agents; Lactones; Lipoproteins; Metformin; Middle Aged; Missouri; Obesity; Orlistat; Placebos; Racial Groups

2002
Role of orlistat in the treatment of obese patients with type 2 diabetes. A 1-year randomized double-blind study.
    Diabetes care, 1998, Volume: 21, Issue:8

    Obesity is an important risk factor for type 2 diabetes. Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors, but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise. The purpose of this study was to assess the impact of treatment with orlistat, a pancreatic lipase inhibitor, on weight loss, glycemic control, and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications.. In a multicenter 57-week randomized double-blind placebo-controlled study, 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged > 18 years, had a BMI of 28-40 kg/m2, and were clinically stable on oral sulfonylureas. Changes in body weight, glycemic control, lipid levels, and drug tolerability were measured.. After 1 year of treatment, the orlistat group lost 6.2 +/- 0.45% (mean +/- SEM) of initial body weight vs. 4.3 +/- 0.49% in the placebo group (P < 0.001). Twice as many patients receiving orlistat (49 vs. 23%) lost > or = 5% of initial body weight (P < 0.001). Orlistat treatment plus diet compared with placebo plus diet was associated with significant improvement in glycemic control, as reflected in decreases in HbA1c (P < 0.001) and fasting plasma glucose (P < 0.001) and in dosage reductions of oral sulfonylurea medication (P < 0.01). Orlistat therapy also resulted in significantly greater improvements than placebo in several lipid parameters, namely, greater reductions in total cholesterol, (P < 0.001), LDL cholesterol (P < 0.001), triglycerides (P < 0.05), apolipoprotein B (P < 0.001), and the LDL-to-HDL cholesterol ratio (P < 0.001). Mild to moderate and transient gastrointestinal events were reported with orlistat therapy, although their association with study withdrawal was low. Fat-soluble vitamin levels generally remained within the reference range, and vitamin supplementation was required in only a few patients.. Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile.

    Topics: Adult; Apolipoproteins; Blood Glucose; Body Weight; Cholesterol; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diet, Reducing; Double-Blind Method; Enzyme Inhibitors; Female; Glycated Hemoglobin; Humans; Lactones; Lipase; Lipoproteins; Male; Middle Aged; Obesity; Orlistat; Placebos; Triglycerides

1998

Other Studies

12 other study(ies) available for orlistat and Diabetes-Mellitus

ArticleYear
Adherence to weight loss medications; post-marketing study from HMO pharmacy data of one million individuals.
    Diabetes research and clinical practice, 2011, Volume: 94, Issue:2

    Post-marketing data on weight-loss medications in free living population are a necessary adjunct to data from clinical trials.. We conducted a population-based analysis of first-time medication users based on HMO pharmacy purchasing data serving > one million adults.. During 5 years, usage of orlistat and sibutramine more than doubled and rates were higher during the months May-Aug. As compared to non-users (n = 1,038,828), annual weight-loss drug users (n = 7175) had higher women proportion, body-mass-index (BMI), bariatric surgery history, and usage of diabetes, depression, and cardiovascular medications (p < 0.001 for all). Among users, men had higher BMI (34.4 kg/m(2) vs. 32.5 kg/m(2)), prevalence of diabetes (25.4% vs. 10.7%) and heart disease (14.2% vs. 3.5%) than women. Mean duration of purchasing weight-loss medications was 2.1 months for orlistat and 2.9 months for sibutramine. Fewer than 2% completed 12 months of weight-loss medication therapy. Among the 25% who continued to purchase at least 4 months, BMI (sub-group analysis) reduced from 33.02 kg/m(2) to 32.04 kg/m(2) (p < 0.001). In a multivariate model, long-term adherence (≥ 4 months) to weight-loss medications was associated with use of sibutramine vs. orlistat (OR = 2.08; 95%CI: 1.76-2.45), and prevalence of diabetes (OR = 1.20; 95%CI: 1.01-1.25). Age, gender, and baseline BMI were not associated with long-term adherence.. Usage of weight-loss drugs is higher among diabetes patients. However, the poor adherence to therapy is substantially below levels reported in clinical trials.

    Topics: Adult; Analysis of Variance; Anti-Obesity Agents; Body Mass Index; Comorbidity; Cyclobutanes; Diabetes Mellitus; Female; Health Care Surveys; Health Maintenance Organizations; Humans; Insurance, Pharmaceutical Services; Israel; Lactones; Logistic Models; Male; Medication Adherence; Middle Aged; Obesity; Odds Ratio; Orlistat; Product Surveillance, Postmarketing; Registries; Time Factors; Treatment Outcome; Weight Loss; Young Adult

2011
Comparison of different methods to assess body composition of weight loss in obese and diabetic patients.
    Diabetes research and clinical practice, 2007, Volume: 77, Issue:3

    Estimating body composition is important to understand the metabolic and cardiovascular effects of adiposity. Estimating changes in body compartments arising from weight loss strategies is equally important to evaluate their benefits and risks, particularly in frail populations (elderly or diabetic), and following bariatric surgery. Body compartments were evaluated in 50 obese subjects (25 diabetic, 25 non-diabetic) before and after a 7 kg weight loss obtained after 6 months of calorie restriction and orlistat. Fat and fat-free mass (FFM) were estimated by bioelectrical impedance analysis (BIA), dual X-ray absorptiometry (DXA), plethysmography (BodPod) and a combination of these in a 3- or 4-compartment model, the latter being considered the reference method. FFM hydration was the ratio of total body water (BIA) to FFM. FFM hydration was significantly higher than classical values (75.9+/-3.0%, P<0.0001), and decreased with weight loss (74.2+/-3.3%). Compared to the 4-compartment, the 3-compartment model gave the most accurate fat and FFM estimation. A significant bias was observed with DXA, BodPod or BIA. Compartment changes induced by weight loss were accurately evaluated by DXA, being particularly precise in the 3-compartment analysis. No effect of diabetes per se was observed. A 3- or 4-compartmental analysis is necessary to accurately estimate body composition and its changes during weight loss.

    Topics: Absorptiometry, Photon; Aged; Body Composition; Body Water; Diabetes Mellitus; Diagnostic Techniques and Procedures; Diet; Electric Impedance; Female; Humans; Lactones; Male; Methods; Middle Aged; Obesity; Orlistat; Plethysmography; Weight Loss

2007
Economic evaluation of orlistat in overweight and obese patients with type 2 diabetes mellitus.
    PharmacoEconomics, 2003, Volume: 21, Issue:7

    To estimate the economic value of pharmacological treatment of type 2 diabetes mellitus in overweight and obese patients using orlistat in addition to standard diabetes therapy (i.e., a sulphonlyurea, metformin or insulin) and weight management strategies as compared with standard diabetes therapy and weight management strategies alone in a US-based healthcare setting. The perspective of the study was from the viewpoint of a US healthcare provider.. Markov state transition model simulating diabetes-related complications and mortality for a period of 11 years. Patients were modelled to continue orlistat therapy for a 52-week period, assuming a 3-year period of weight regain where after 3 years bodyweight would match that of the placebo group. The impact of orlistat on glycosylated haemoglobin (HbA(1c)) values was evaluated directly using data from four randomised, placebo-controlled, 1-year trials of orlistat in overweight or obese adults with type 2 diabetes who also received standard diabetes pharmacotherapy and intensive lifestyle modification. Incidence rates of micro- and macrovascular complications associated with type 2 diabetes and the estimated relative reduction in incidence rates associated with a decrease in mean updated HbA(1C) values were derived from the United Kingdom Prospective Diabetes Study (UKPDS) estimates for a reference population of male patients, 52 years of age. US cost estimates were derived from published sources and presented in 2001 US dollars. Discounting of 3% was applied. Probabilistic sensitivity analysis was applied to evaluate the robustness of the results of the persistence of the effect of orlistat after treatment.. Average costs and event-free life-years gained during the 11-year period expressed as the incremental costs divided by the incremental gain in life expectancy.. Treatment with orlistat, 120 mg three times daily, increased event-free life expectancy by 0.13 years over an 11-year period. Average treatment costs were estimated to be 19,987 US dollars in the orlistat group compared with 18,865 US dollars in the group that received diabetes medication and weight management alone. This translated into a cost-effectiveness ratio of 8327 US dollars per event-free life-year gained.. Adding orlistat as a pharmacological treatment to conventional diabetes and weight management approaches seems to be a cost-effective treatment option for overweight and obese patients with type 2 diabetes.

    Topics: Anti-Obesity Agents; Body Weight; Cost-Benefit Analysis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Female; Health Care Costs; Humans; Hypoglycemic Agents; Lactones; Male; Markov Chains; Models, Economic; Obesity; Orlistat; Randomized Controlled Trials as Topic; United States

2003
[A drug help in reducing? Risk profile decides whether and how].
    MMW Fortschritte der Medizin, 2003, May-22, Volume: 145, Issue:21

    Topics: Adult; Anti-Obesity Agents; Appetite Depressants; Blood Glucose; Body Mass Index; Cyclobutanes; Diabetes Complications; Diabetes Mellitus; Humans; Hypertension; Lactones; Obesity; Orlistat; Risk Factors; Time Factors

2003
The implementation of nutritional advice for people with diabetes.
    Diabetic medicine : a journal of the British Diabetic Association, 2003, Volume: 20, Issue:10

    These consensus-based recommendations emphasize the practical implementation of nutritional advice for people with diabetes, and describe the provision of services required to provide the information. Important changes from previous recommendations include greater flexibility in the proportions of energy derived from carbohydrate and monounsaturated fat, further liberalization in the consumption of sucrose, more active promotion of foods with a low glycaemic index, and greater emphasis on the provision of nutritional advice in the context of wider lifestyle changes, particularly physical activity. Monounsaturated fats are now promoted as the main source of dietary fat because of their lower susceptibility to lipid peroxidation and consequent lower atherogenic potential. Consumption of sucrose for patients who are not overweight can be increased up to 10% of daily energy provided that this is eaten in the context of a healthy diet and distributed throughout the day [corrected]. Evidence is presented for the effectiveness of advice provided by trained dieticians. The increasing evidence for the importance of good metabolic control and the growing requirement for measures to prevent Type 2 diabetes in an increasingly obese population will require major expansion of dietetic services if the standards in National Service Frameworks are to be successfully implemented.

    Topics: Adolescent; Adult; Aged; Anti-Obesity Agents; Asian People; Body Composition; Child; Cyclobutanes; Diabetes Mellitus; Diet; Dietary Services; Exercise; Feeding and Eating Disorders; Female; Glycemic Index; Humans; Insulin; Lactones; Male; Middle Aged; Nutritional Physiological Phenomena; Orlistat; Patient Education as Topic; Pregnancy; Pregnancy in Diabetics; Selective Serotonin Reuptake Inhibitors; Weight Loss

2003
Response to Lamotte et Al. "A health economic model to assess the long-term effects and cost-effectiveness of orlistat in obese type 2 diabetic patients.".
    Diabetes care, 2002, Volume: 25, Issue:10

    Topics: Cost-Benefit Analysis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Humans; Hypoglycemic Agents; Lactones; Obesity; Orlistat

2002
Diabetic ketoacidosis associated with orlistat treatment.
    Diabetes care, 2001, Volume: 24, Issue:3

    Topics: Adolescent; Anti-Obesity Agents; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Diet, Reducing; Female; Humans; Lactones; Obesity; Orlistat; Weight Gain

2001
Principles for enhanced recruitment of subjects in a large clinical trial. the XENDOS (XENical in the prevention of Diabetes in Obese Subjects) study experience.
    Controlled clinical trials, 2001, Volume: 22, Issue:5

    In most clinical trials it is problematic to recruit enough patients within a reasonable time period. Prolonged or inefficient recruitment or both can have negative scientific and economic consequences. The XENDOS (XENical in the prevention of Diabetes in Obese Subjects) study is an ongoing randomized, double-blind, placebo-controlled, prospective, multicenter trial investigating whether orlistat combined with hypocaloric diet and moderate physical exercise can reduce the incidence of diabetes in obese subjects. To implement the XENDOS protocol and recruit the study patients, we designed a system for centralized patient recruitment and centralized scheduling of patients and staff at the 22 collaborating centers. The recruitment and inclusion phase was divided into a series of different consecutive examinations of increasing complexity. Relatively simple initial examinations enabling a large throughput of patients were followed by more detailed examinations of fewer subjects, by then known to fulfil some of the study-specific requirements. With the aid of object-oriented techniques, the software was modularized to enable concurrent engineering. We also selected a structure where plug-in modules handling specific tasks could be added to the system as needed. The design was supported by a flow-oriented view of the progress of the patients through the study. With this overall solution we managed to include 3305 subjects (98.8% of the requested number) within less than 4 months. The sex distribution (44.8% men) and the number of patients with impaired glucose tolerance (IGT), (21.1%) were in close accordance with, or far better than, the requirements of the protocol (45% men, at least 10% IGT patients). The basic design of the XENDOS information system can be adapted to fulfil the requirements of other study protocols within the fields of obesity, diabetes, hypertension, coronary heart disease, etc. Shortening the recruitment and inclusion phase of large clinical trials is of great value both to be medical society and the pharmaceutical industry.

    Topics: Adult; Anti-Obesity Agents; Diabetes Mellitus; Double-Blind Method; Female; Humans; Lactones; Male; Middle Aged; Multicenter Studies as Topic; Obesity; Orlistat; Patient Selection; Randomized Controlled Trials as Topic; Sweden

2001
Obesity and Type 2 diabetes mellitus.
    Diabetic medicine : a journal of the British Diabetic Association, 2000, Volume: 17, Issue:5

    Topics: Anti-Obesity Agents; Blood Glucose; Body Mass Index; Diabetes Mellitus; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Lactones; Male; Metformin; Middle Aged; Obesity; Orlistat; Weight Loss

2000
Henry Arthur Solomon, MD: a conversation with the editor. Interview by Roberts WC.
    The American journal of cardiology, 2000, Jul-15, Volume: 86, Issue:2

    Topics: Anti-Obesity Agents; Cardiology; Diabetes Mellitus; Humans; Lactones; New York City; Obesity; Orlistat

2000
Obesity: a time bomb to be defused.
    Lancet (London, England), 1998, Jul-18, Volume: 352, Issue:9123

    Topics: Adult; Aged; Anti-Obesity Agents; Body Mass Index; Diabetes Mellitus; Enzyme Inhibitors; Female; Health Care Costs; Humans; Hypertension; Lactones; Lipase; Male; Middle Aged; Morbidity; Obesity; Orlistat; Risk Factors; United States; Weight Loss

1998
[Drug clinics. How I treat various metabolic diseases treated by a drug intervention that targets the intestine].
    Revue medicale de Liege, 1998, Volume: 53, Issue:11

    Besides the classical dietary regimen, it is possible to use specific pharmacological approaches, targeted at the intestine, in order to treat some metabolic disorders. Three approaches will be described: anionic resins for treating hypercholesterolaemia, alpha-glucosidase inhibitors for treating diabetes mellitus and reactive hypoglycaemia, and intestinal lipase inhibitors for treating obesity. All these drugs are based on original concepts, but their clinical use is often limited by the occurrence of digestive side-effects. The latter may generally be reduced by progressive and individual titration of the dosage of each drug and/or by following an appropriate diet.

    Topics: Acarbose; Anion Exchange Resins; Anti-Obesity Agents; Cholestyramine Resin; Diabetes Mellitus; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Humans; Hypercholesterolemia; Hypoglycemia; Hypoglycemic Agents; Hypolipidemic Agents; Intestine, Small; Lactones; Lipase; Metabolic Diseases; Orlistat; Trisaccharides

1998