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Completed

NCT Number: NCT05918068

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maysan Centre for Diabetes and Endocrinology

Maysan Governorate, 383421, Iraq

About this study

Numerous organs might suffer long-term harm, malfunction, and failure as a result of type 2 diabetes. While the illness may initially cause weight loss, frequent urination, thirst, and hazy vision, the long-term repercussions may include the gradual onset of specific issues such as cardiovascular disease (CVD), retinopathy, which may culminate in blindness, and renal disease. The risk of foot ulcers, Charcot joints, and symptoms of autonomic dysfunction, such as sexual dysfunction, is associated with renal failure and/or neuropathy. Diabetes and vitamin B6 have both been linked. It is not apparent, therefore, whether diabetes is a consequence of low P.L.P. levels, a cause, or both. According to some study, diabetes may develop as a consequence of low P.L.P. levels, however other studies suggest that diabetes decreases P.L.P. levels. Although the physiological and molecular pathways behind these beneficial effects on diabetic pathology and related repercussions are not completely understood, multiple investigations have demonstrated that B6 therapy has good effects. There are numerous ways that pyridoxal 5-phosphate deficiency affects diabetes. As an essential element for numerous enzymes that contribute to this process, pyridoxal-5-phosphate can, for example, influence the route that converts tryptophan into niacin. It has been proven that the metabolites produced when this pathway is damaged lessen the bioactivity of insulin and cause insulin resistance, a T2D symptom . Pyridoxal-5-phosphate may influence insulin resistance via modulating the expression of adipogenesis-related genes. The degradation of co-enzyme-dependent enzymes like (C.B.S.) and (C.G.L.), which rely on pyridoxal-5-phosphate, may also promote insulin resistance via elevating homocysteine levels .

This research intends to examine the impact of pyridoxine adjuvant treatment on the blood glucose level in type 2 diabetes patients.

This is a randomized controlled open-label interventional study. T2DM patients who receive either (metformin with pyridoxine) or (metformin only) daily and T2DM patients treated with non-pharmacological therapy (lifestyle modification) will be included in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

Metformin 500 mg/day

Drug

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

Other names: Metformin 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

Other names: Combination group

non-pharmacological therapy

Other

non-pharmacological therapy (healthy lifestyle modifications)

Other names: control group

Primary outcomes

  1. Fasting plasma glucose (FPG).

    Time frame: Change from baseline, to one month

    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

  2. Glycated Hemoglobin (HbAlc)

    Time frame: Change from baseline, to one month

    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.

Secondary outcomes

  1. Vitamin B6

    Time frame: Change from baseline, to one month

    The reference range for pyridoxal phosphate (PLP), the biologically active form of vitamin B6, is 5-50 µg/L.

  2. Fasting plasma insulin (F.P.I.).

    Time frame: Change from baseline, to one month

    The insulin fasting blood test is chiefly used to test insulin levels and diagnose diabetes and insulin resistance.

  3. Insulin resistance (HOMA-IR).

    Time frame: Change from baseline, to one month

    Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.

  4. Indoleamine 2,3 dioxygenase (IDO)

    Time frame: Change from baseline, to one month

    Has the potential role of indoleamine 2,3 dioxygenase (IDO) as a predictive and therapeutic target for diabetes treatment

Sponsors and collaborators

Lead sponsor

Al-Rasheed University College

Other

Registry information

Official study title

Evaluation of the Role of Pyridoxine Adjuvant Therapy on the Blood Glucose Level in Type 2 Diabetic Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 26, 2023
Registry last updated
Jun 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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