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Pyridoxine Effect on the Blood Glucose Level in Type 2 Diabetic Patients

NCT05918068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2023-06-26

No results posted yet for this study

Summary

Pyridoxal-5-phosphate (P.L.P.), the biologically active form of vitamin B6, is a coenzyme in 150 enzymatic reactions, including amino acid, carbohydrate, and lipid metabolism. Neurotransmitter production and breakdown depend on it. Additionally, it functions as an antioxidant by suppressing reactive oxygen species and mitigating the development of advanced glycation end products. Humans recycle P.L.P. from dietary B6 vitamins, and this molecule has been related to various clinically relevant diseases. Pyridoxine as an additional therapy for type 2 diabetes will be examined in this study.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Metformin 500 mg/day

Metformin 500 mg/day in addition to non-pharmacological therapy

COMBINATION_PRODUCT

Metformin 500 mg/day plus vitamin B6 300 mg/day

Metformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy

OTHER

non-pharmacological therapy

non-pharmacological therapy (healthy lifestyle modifications)

Sponsors & Collaborators

  • Al-Rasheed University College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-04-01
Completion
2023-04-01

Countries

  • Iraq

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05918068 on ClinicalTrials.gov