c-peptide and trichlorosucrose

The discovery of gut sweet taste receptors has led to speculations that non-nutritive sweeteners, including sucralose, may affect glucose control. A double-blind, parallel, randomized clinical trial, reported here and previously submitted to regulatory agencies, helps to clarify the role of sucralose in this regard. This was primarily an out-patient study, with 4-week screening, 12-week test, and 4-week follow-up phases. Normoglycemic male volunteers (47) consumed ∼333.3 mg encapsulated sucralose or placebo 3x/day at mealtimes. HbA1c, fasting glucose, insulin, and C-peptide were measured weekly. OGTTs were conducted in-clinic overnight, following overnight fasting twice during screening phase, twice during test phase, and once at follow-up. Throughout the study, glucose, insulin, C-peptide and HbA1c levels were within normal range. No statistically significant differences between sucralose and placebo groups in change from baseline for fasting glucose, insulin, C-peptide and HbA1c, no clinically meaningful differences in time to peak levels or return towards basal levels in OGTTs, and no treatment group differences in mean glucose, insulin, or C-peptide AUC change from baseline were observed. The results of other relevant clinical trials and studies of gastrointestinal sweet taste receptors are compared to these findings. The collective evidence supports that sucralose has no effect on glycemic control.

Topics: Blood Glucose; C-Peptide; Diabetes Mellitus, Type 2; Double-Blind Method; Fasting; Glycated Hemoglobin; Homeostasis; Humans; Insulin; Male; Sucrose; Sweetening Agents

Artificial sweeteners were thought to be metabolically inactive, but after demonstrating that the gustatory mechanism was also localized in the small intestine, suspicions about the metabolic effects of artificial sweeteners have emerged. The objective of this study was to determine the effect of artificial sweeteners (aspartame and sucralose) on blood glucose, insulin, c-peptide and glucagon-like peptide-1 (GLP-1) levels.. Eight newly diagnosed drug-naive type 2 diabetic patients (mean age 51.5±9.2 years; F/M: 4/4) and eight healthy subjects (mean age 45.0±4.1 years; F/M: 4/4) underwent 75 g oral glucose tolerance test (OGTT). During OGTT, glucose, insulin, c-peptide and GLP-1 were measured at 15- min intervals for 120 min. The OGTTs were performed at three settings on different days, where subjects were given 72 mg of aspartame and 24 mg of sucralose in 200 ml of water or 200 ml of water alone 15 min before OGTT in a single-blinded randomized order.. In healthy subjects, the total area under the curve (AUC) of glucose was statistically significantly lower in the sucralose setting than in the water setting (P=0.002). There was no difference between the aspartame setting and the water setting (P=0.53). Total AUC of insulin and c-peptide was similar in aspartame, sucralose and water settings. Total AUC of GLP-1 was significantly higher in the sucralose setting than in the water setting (P=0.04). Total AUC values of glucose, insulin, c-peptide and GLP-1 were not statistically different in three settings in type 2 diabetic patients.. Sucralose enhances GLP-1 release and lowers blood glucose in the presence of carbohydrate in healthy subjects but not in newly diagnosed type 2 diabetic patients.

Topics: Adult; Area Under Curve; Aspartame; Blood Glucose; C-Peptide; Diabetes Mellitus, Type 2; Dietary Carbohydrates; Female; Glucagon; Glucagon-Like Peptide 1; Glucose; Glucose Tolerance Test; Healthy Volunteers; Humans; Insulin; Male; Middle Aged; Sucrose; Sweetening Agents

To investigate the effect of 3-months' daily administration of high doses of sucralose, a non-nutritive sweetener, on glycemic control in subjects with type 2 diabetes.. A multicenter, double-blind, placebo-controlled, randomized study, consisting of a 6-week screening phase, a 13-week test phase, and a 4-week follow-up phase.. Subjects with type 2 diabetes (age range 31 to 70 years) entered the test phase of this study; 128 subjects completed the study. The subjects were recruited from 5 medical centers across the United States and were, on average, obese.. Subjects were randomly assigned to receive either placebo (cellulose) capsules (n=69) or 667 mg encapsulated sucralose (n=67) daily for the 13-week test phase. All subjects blindly received placebo capsules during the last 4 weeks of the screening phase and for the entire 4-week follow-up phase.. Glycated hemoglobin (HbA1c), fasting plasma glucose, and fasting serum C-peptide were measured approximately every 2 weeks to evaluate blood glucose homeostasis. Data were analyzed by analysis of variance using repeated measures.. There were no significant differences between the sucralose and placebo groups in HbA1c, fasting plasma glucose, or fasting serum C-peptide changes from baseline. There were no clinically meaningful differences between the groups in any safety measure.. This study demonstrated that, similar to cellulose, sucralose consumption for 3 months at doses of 7.5 mg/kg/day, which is approximately three times the estimated maximum intake, had no effect on glucose homeostasis in individuals with type 2 diabetes. Additionally, this study showed that sucralose was as well-tolerated by the study subjects as was the placebo.

Topics: Administration, Oral; Adult; Aged; Analysis of Variance; Blood Glucose; C-Peptide; Diabetes Mellitus, Type 2; Double-Blind Method; Fasting; Female; Glycated Hemoglobin; Homeostasis; Humans; Male; Middle Aged; Patient Compliance; Sucrose; Sweetening Agents

To examine the effect of a single high oral dose of the novel noncaloric sweetener sucralose on short-term glucose homeostasis in patients with IDDM or NIDDM.. A total of 13 IDDM and 13 NIDDM patients with glycosylated hemoglobin levels < 10% completed this double-blind cross-over study. After an overnight fast, patients were administered opaque capsules containing either 1,000 mg sucralose or cellulose placebo, followed by a standardized 360-kcal liquid breakfast. Plasma glucose and serum C-peptide levels were measured over the next 4 h.. Regardless of the type of diabetes, areas under the curves for changes of plasma glucose and serum C-peptide levels after sucralose administration were not significantly different from those after placebo. During test meals with sucralose, one episode of symptomatic hypoglycemia occurred in each of three IDDM patients, but these episodes were not considered the result of sucralose administration.. The present results support the conclusion that sucralose consumption does not adversely affect short-term blood glucose control in patients with diabetes.

Topics: Administration, Oral; Adult; Blood Glucose; C-Peptide; Cross-Over Studies; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Double-Blind Method; Fasting; Female; Glycated Hemoglobin; Homeostasis; Humans; Male; Middle Aged; Sucrose; Sweetening Agents

Dessert compositions may conform to diabetic diet when it contains low sugar or artificial sweetener to replace sugar. However, it is still questionable whether glycemic control in type 2 diabetes patients is improved by the use of diet-conforming dessert compositions.. To compare, in type 2 diabetes patients, the glycemic, insulin, and C-peptide responses to seven modified dessert compositions for diabetics (D-dessert) with the response to seven similar desserts of non-modified composition, used as control desserts (C-dessert).. Seventy type 2 diabetes patients were allocated to seven groups of ten. On three occasions, each patient received either the meal which consisted of bread and cheese, or the meal and D-dessert, or the meal and the respective C-dessert. Differences in postprandial glucose, insulin, and C-peptide were evaluated using analysis of repeated measures at 0, 30, 60, 90, and 120 min after consumption.. D-cake and D-pastry cream resulted in lower glucose levels (8.81 ± 0.32 mmol/l and 8.67 ± 0.36 mmol/l, respectively) and D-strawberry jelly in lower insulin levels (16.46 ± 2.66 μU/ml) than the respective C-desserts (9.99 ± 0.32 mmol/l for C-cake, 9.28 ± 0.36 mmol/l for C-pastry cream, and 27.42 ± 2.66 μU/ml for C-strawberry jelly) (p < 0.05). Compared with the meal, D-cake did not increase glucose or insulin levels (p < 0.05), while C-cake did (p < 0.05). D-pastry cream increased glucose to a lesser extent than C-pastry cream (p < 0.05). Similar effects were reported for D-milk dessert, D-millefeuille, and D-chocolate on glucose, insulin, and C-peptide at specific timepoints. D-crème caramel showed no effect.. Some desserts formulated with sugar substitutes and soluble fiber may have a favorable effect on postprandial levels of glucose, insulin, and C-peptide in type 2 diabetic patients.

Topics: Aged; C-Peptide; Dextrins; Diabetes Mellitus, Type 2; Diet, Diabetic; Female; Glucose; Humans; Insulin; Male; Middle Aged; Postprandial Period; Sucrose; Sweetening Agents