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pyridoxal phosphate and Diabetic Neuropathies

pyridoxal phosphate has been researched along with Diabetic Neuropathies in 8 studies

Pyridoxal Phosphate: This is the active form of VITAMIN B 6 serving as a coenzyme for synthesis of amino acids, neurotransmitters (serotonin, norepinephrine), sphingolipids, aminolevulinic acid. During transamination of amino acids, pyridoxal phosphate is transiently converted into pyridoxamine phosphate (PYRIDOXAMINE).
pyridoxal 5'-phosphate : The monophosphate ester obtained by condensation of phosphoric acid with the primary hydroxy group of pyridoxal.

Diabetic Neuropathies: Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)

Research Excerpts

ExcerptRelevanceReference
"Gabapentin (GBP) is an FDA-approved drug for the treatment of partial and secondary generalized seizures, apart from being used for diabetic neuropathic pain."1.62In-Silico Validation and Fabrication of Matrix Diffusion-Based Polymeric Transdermal Patches for Repurposing Gabapentin Hydrochloride in Neuropathic Pain. ( Agarwal, S; Agarwal, V; Kaur, H; Kaur, R; Pancham, P; Singh, M, 2021)
"Painful diabetic neuropathy causes hyperalgesia and does not respond to commonly used analgesics such as non-steroidal anti-inflammatory drugs or opioids at doses below those producing disruptive side effects."1.35Modulation of P2X receptors in dorsal root ganglion neurons of streptozotocin-induced diabetic neuropathy. ( Honda, K; Katsuragi, T; Koguchi, M; Migita, K; Moriyama, T; Takano, Y; Ueno, S, 2009)

Research

Studies (8)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (25.00)29.6817
2010's5 (62.50)24.3611
2020's1 (12.50)2.80

Authors

AuthorsStudies
Singh, M1
Agarwal, S1
Pancham, P1
Agarwal, V1
Kaur, H1
Kaur, R1
Trippe, BS1
Barrentine, LW1
Curole, MV1
Tipa, E1
Migita, K1
Moriyama, T1
Koguchi, M1
Honda, K1
Katsuragi, T1
Takano, Y1
Ueno, S1
Walker, MJ1
Morris, LM1
Cheng, D1
Shevalye, H1
Watcho, P1
Stavniichuk, R1
Dyukova, E1
Lupachyk, S1
Obrosova, IG1
Fonseca, VA1
Lavery, LA1
Thethi, TK1
Daoud, Y1
DeSouza, C1
Ovalle, F1
Denham, DS1
Bottiglieri, T1
Sheehan, P1
Rosenstock, J1
Vinik, AI1
Okada, H1
Moriwaki, K1
Kanno, Y1
Sugahara, S1
Nakamoto, H1
Yoshizawa, M1
Suzuki, H1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A 24 Week, Double-blind, Placebo-controlled, Multisite Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)[NCT00726713]Phase 4214 participants (Actual)Interventional2008-06-30Completed
Assessment of Designer Functional Foods on Parameters of Metabolic and Vascular Status in Individuals With Prediabetes.[NCT02400450]0 participants (Actual)Interventional2016-09-30Withdrawn
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

(Exploratory) Change From Baseline in Levels of Hs-CRP at Week 24

(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including hs-CRP (NCT00726713)
Timeframe: Analyte levels were taken at 0 (Baseline) and 24 weeks

,
Interventionmg/L (Mean)
hs-CRP (mg/L), Baselinehs-CRP, Change from BL, Week 24
Metanx6.46-0.71
Placebo7.440.13

(Exploratory) Change From Baseline in Levels of IL-6 and TNF-α, at Week 24

(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory marker levels, including IL-6 and TNF-α (NCT00726713)
Timeframe: Analyte levels were taken at 0 (Baseline) and 24 weeks

,
Interventionpg/mL (Mean)
IL-6 (pg/mL), BaselineIL-6, Change from BL, Week 24TNF-a (pg/mL), BaselineTNF-a, Change from BL, Week 24
Metanx3.66-0.251.690.03
Placebo3.680.072.01-0.04

(Exploratory) Change From Baseline in Levels Potential Antioxidant (PAO) at Week 24

(Exploratory) To determine if Metanx® affects a subject's plasma oxidative stress and inflammatory markers levels including Potential Antioxidant (PAO) (NCT00726713)
Timeframe: Analyte levels were taken at 0 (Baseline) and 24 weeks

,
Interventionµmol/L (Mean)
PAO (µmol/L), BaselinePAO, Change from BL, Week 24
Metanx1094.527.95
Placebo1102.155.29

(Exploratory) Change From Baseline in the Hospital Anxiety and Depression Scale (HADS) Question Inventory at Week 24

The Hospital Anxiety and Depression Scale (HADS) consists of a 14-item questionnaire that provides a measurement of depression. Each item is rated on a 4-point scale, giving a maximum scores of 21 for the most severe depression. Depression was evaluated using the Hospital Anxiety and Depression Scale (HADS) question inventory at Baseline, and 24-week evaluation visits (NCT00726713)
Timeframe: HADS Scores scores were taken at 0 (Baseline) and 24 weeks

,
Interventionunits on a scale (0-21) (Mean)
HADS Depression, BaselineHADS Depression, Change from BL, Week 24
Metanx4.16-1.03
Placebo4.42-0.45

Change From Baseline in 10-point Visual Analog Scale(VAS) at Week 24

"To determine if Metanx® (compared to placebo) affects a subject's lower extremity pain level using a 10-point Visual Analog Scale at Baseline and 24-week evaluation visits.~The Visual Analog Scale (VAS) measures a patients sensation of pain. A 10-cm visual analog scale is used. A measurement on the 10 cm analog scale is used to quantify the level of pain indicated with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable." (NCT00726713)
Timeframe: VAS scores were taken at 0 (Baseline) and 24 weeks

,
Interventionunits on a scale (0-10) (Mean)
VAS BaselineVAS, Change from BL, Week 24
Metanx3.26-0.27
Placebo3.25-0.03

Change From Baseline in Neuropathy Disability Score (NDS)at Week 16 and 24

"This outcome was taken to determine if Metanx® (compared to placebo) has an effect on clinical examination as determined by the Neuropathy Disability Score (NDS)~The Neuropathy Disability Score (NDS) evaluates the severity of individual symptoms of neuropathy. A simple visual numeric distress scale is used that ranges from 0 to 10. The most favorable score is 0, which indicates an absence of symptoms. The most severe symptoms possible would be recorded as a score of 10." (NCT00726713)
Timeframe: NDS scores were taken at 0 (Baseline), 16, and 24 weeks

,
Interventionunits on a scale (0-10) (Mean)
BaselineChange from Baseline Week 16Change from Baseline Week 24
Metanx7.51-0.78-0.47
Placebo7.47-0.18-0.36

Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)

"This measure was taken to determine if Metanx® (compared to placebo) changes neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)~The Neuropathy Total Symptom Score-6 Scale (NTSS-6) is a validated scale that evaluates individual neuropathy sensory symptoms in patients with diabetes mellitus (DM) and diabetic peripheral neuropathy (DPN). This scale was a modified 6 item scale that consists of yes or no questions. Scores range between 0 and 21.96, a higher score indicates greater severity of symptoms. After adjusting for baseline measurements scores are reflected as negative numbers. Negative numbers indicate improvement in symptoms. ie. a change from baseline after 24 weeks of -2 would be a greater improvement than a change in baseline of -1 after 24 weeks." (NCT00726713)
Timeframe: NTSS-6 scores were taken at 0 (Baseline), 16, and 24 weeks

,
Interventionunits on a scale (0-6) (Mean)
BaselineChange from Baseline Week 16Change from Baseline Week 24
Metanx3.73-0.09-0.96
Placebo3.45-0.40-0.53

Change From Baseline in Plasma Marker Levels of Total Folate and Total Methyl Malonic Acid (MMA) at Week 16 and 24

To determine if Metanx® (compared to placebo) affects a change in subject's total folate and total methyl malonic acid (MMA) at week 16 and 24 (NCT00726713)
Timeframe: Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks

,
Interventionnmol/L (Mean)
Total Folate (nmol/L) at BaselineTotal Folate, Change from BL Week 16Total Folate, Change from BL Week 24Total methyl malonic acid (MMA) (nmol/L) at BLTotal MMA, Change from BL Week 16Total MMA, Change from BL Week 24
Metanx42.197.257.53186.16-56.38-63.29
Placebo43.04-1.07-2.75195.7213.89-15.42

Change From Baseline in SF-36 MCS and SF-36 PCS at Week 24

"To determine if Metanx® (compared to placebo) affects a subject's quality of life as determined by the SF-36 questionnaire~The Short Form- 36 Mental Component Summary (SF-36 MCS) and SF-36 Physical Component Summary (SF-36 PCS) both measure health related quality of life, the MCS quantifying mental health and the PCS quantifying physical function. They are both scored on 100 point scales with 0 representing the worst possible outcome and 100 representing the most optimal possible scoring" (NCT00726713)
Timeframe: SF-36 MCS and SF-36 PCS scores were measured at 0 (Baseline) and 24 weeks

,
Interventionunits on a scale (0-100) (Mean)
SF-36 PCS, BaselineSF-36 PCS, Change from BL, Week 24SF-36 MCS, BaselineSF-36 MCS, Change from BL, Week 24
Metanx40.740.0350.961.99
Placebo39.030.8752.66-0.29

Change From Baseline in Total Homocysteine at Week 16 and 24

To determine if Metanx® (compared to placebo) affects change in subjects total homocysteine levels (NCT00726713)
Timeframe: Change from Baseline in Plasma Marker Levels at 0 (Baseline), 16, and 24 weeks

,
Interventionµmol/L (Mean)
Total homocysteine (µmol/L) at BaselineTotal homocysteine, Change from BL Week 16Total homocysteine, Change from BL Week 24
Metanx9.71-2.70-2.68
Placebo9.470.580.48

Change From Baseline in Vibration Perception Threshold (VPT) at 24 Weeks

Vibration Perception Threshold (VPT) 25-45 volts at hallux on either leg as measured by VPT meter on the great toe of each foot. Mean VPT averaged across both toes. (NCT00726713)
Timeframe: VPT was measured a 0 (baseline), and 24 weeks

,
Interventionvolts (Mean)
BaselineChange from Baseline Week 24
Metanx32.16-1.96
Placebo33.88-3.27

Trials

2 trials available for pyridoxal phosphate and Diabetic Neuropathies

ArticleYear
Metanx in type 2 diabetes with peripheral neuropathy: a randomized trial.
    The American journal of medicine, 2013, Volume: 126, Issue:2

    Topics: Adult; Aged; Aged, 80 and over; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Double-Blind Metho

2013
Vitamin B6 supplementation can improve peripheral polyneuropathy in patients with chronic renal failure on high-flux haemodialysis and human recombinant erythropoietin.
    Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2000, Volume: 15, Issue:9

    Topics: Chronic Disease; Diabetic Neuropathies; Erythropoietin; Female; Glomerulonephritis; Humans; Kidney F

2000

Other Studies

6 other studies available for pyridoxal phosphate and Diabetic Neuropathies

ArticleYear
In-Silico Validation and Fabrication of Matrix Diffusion-Based Polymeric Transdermal Patches for Repurposing Gabapentin Hydrochloride in Neuropathic Pain.
    CNS & neurological disorders drug targets, 2021, Volume: 20, Issue:6

    Topics: Analgesics; Computer Simulation; Diabetic Neuropathies; Drug Repositioning; Gabapentin; Humans; Mole

2021
Nutritional management of patients with diabetic peripheral neuropathy with L-methylfolate-methylcobalamin-pyridoxal-5-phosphate: results of a real-world patient experience trial.
    Current medical research and opinion, 2016, Volume: 32, Issue:2

    Topics: Adult; Aged; Diabetic Neuropathies; Female; Humans; Male; Middle Aged; Pain; Pyridoxal Phosphate; Qu

2016
Modulation of P2X receptors in dorsal root ganglion neurons of streptozotocin-induced diabetic neuropathy.
    Neuroscience letters, 2009, Mar-13, Volume: 452, Issue:2

    Topics: Adenosine Triphosphate; Animals; Diabetes Mellitus, Experimental; Diabetic Neuropathies; Disease Mod

2009
Improvement of cutaneous sensitivity in diabetic peripheral neuropathy with combination L-methylfolate, methylcobalamin, and pyridoxal 5'-phosphate.
    Reviews in neurological diseases, 2010, Volume: 7, Issue:4

    Topics: Diabetes Mellitus, Type 2; Diabetic Neuropathies; Drug Therapy, Combination; Follow-Up Studies; Huma

2010
Metanx alleviates multiple manifestations of peripheral neuropathy and increases intraepidermal nerve fiber density in Zucker diabetic fatty rats.
    Diabetes, 2012, Volume: 61, Issue:8

    Topics: Animals; Diabetes Mellitus, Type 2; Diabetic Neuropathies; Disease Models, Animal; Folic Acid; Hyper

2012
A medicinal food provides food for thought in managing diabetic neuropathy.
    The American journal of medicine, 2013, Volume: 126, Issue:2

    Topics: Diabetes Mellitus, Type 2; Diabetic Neuropathies; Female; Folic Acid; Humans; Male; Pyridoxal Phosph

2013