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

NCT05918068 | Completed

• 1 other identifier: AR200108
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Fasting plasma glucose (FPG).

  A fasting plasma glucose test, also known as a fasting glucose test (FGT), is a test that can be used to help diagnose diabetes or pre-diabetes.The expected values for normal fasting blood glucose concentration are between 70 mg/dL (3.9 mmol/L) and 100 mg/dL (5.6 mmol/L). When fasting blood glucose is between 100 to 125 mg/dL (5.6 to 6.9 mmol/L), changes in lifestyle and monitoring glycemia are recommended

  Change from baseline, to one month

• Glycated Hemoglobin (HbAlc)

  A normal A1C level is below 5.7%, a level of 5.7% to 6.4% indicates prediabetes and a level of 6.5% or more indicates diabetes.

  Change from baseline, to one month

Secondary Outcomes (4)

• Vitamin B6

  Change from baseline, to one month

• Fasting plasma insulin (F.P.I.).

  Change from baseline, to one month

• Insulin resistance (HOMA-IR).

  Change from baseline, to one month

• Indoleamine 2,3 dioxygenase (IDO)

  Change from baseline, to one month

Study Arms (3)

Control group

OTHER

Newly diagnosed patients with T2DM, treated with non-pharmacological therapy (lifestyle modification).

Other: non-pharmacological therapy

Metformin only group

ACTIVE COMPARATOR

T2DM patients treated with metformin 500 mg/day in addition to non-pharmacological therapy (lifestyle modification)

Drug: Metformin 500 mg/day; Other: non-pharmacological therapy

Combination group

EXPERIMENTAL

T2DM patients treated with metformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy (lifestyle modification)

Drug: Metformin 500 mg/day; Combination Product: Metformin 500 mg/day plus vitamin B6 300 mg/day; Other: non-pharmacological therapy

Interventions

Metformin 500 mg/day DRUG

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

Also known as: Metformin group

Combination group; Metformin only group

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

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

Also known as: Combination group

Combination group

non-pharmacological therapy OTHER

non-pharmacological therapy (healthy lifestyle modifications)

Also known as: control group

Combination group; Control group; Metformin only group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes mellitus newly diagnosed patient with age (Above 30) years.
• HbA1c less than or equal to 7.5%.

You may not qualify if:

• Type 1 Diabetes mellitus.
• Concomitant chronic diseases (Rheumatoid arthritis, anemia, asthma, endocrine disorders, renal failure, alcoholics, and patient on anti-T.B. or anti-epileptics).
• Females should be neither pregnant nor on oral contraceptive drugs.
• Not taking any vitamin or mineral supplementation.
• Should have no history of recent acute infection (within the previous two weeks).

Sponsors & Collaborators

• Al-Rasheed University College: lead

Study Sites (1)

Maysan Centre for Diabetes and Endocrinology

Maysan Governorate, 383421, Iraq

Location

Related Publications (3)

• Mascolo E, Verni F. Vitamin B6 and Diabetes: Relationship and Molecular Mechanisms. Int J Mol Sci. 2020 May 23;21(10):3669. doi: 10.3390/ijms21103669.

  PMID: 32456137 BACKGROUND

• Merigliano C, Mascolo E, Burla R, Saggio I, Verni F. The Relationship Between Vitamin B6, Diabetes and Cancer. Front Genet. 2018 Sep 13;9:388. doi: 10.3389/fgene.2018.00388. eCollection 2018.

  PMID: 30271425 BACKGROUND

• Petersmann A, Muller-Wieland D, Muller UA, Landgraf R, Nauck M, Freckmann G, Heinemann L, Schleicher E. Definition, Classification and Diagnosis of Diabetes Mellitus. Exp Clin Endocrinol Diabetes. 2019 Dec;127(S 01):S1-S7. doi: 10.1055/a-1018-9078. Epub 2019 Dec 20. No abstract available.

  PMID: 31860923 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Vitamin B 6; Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 26, 2023
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-05

Locations

IR (1)