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

June 15, 2023 updated by: Al-Rasheed University College

Evaluation of the Role of Pyridoxine Adjuvant Therapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Maysan Governorate, Iraq, 383421
        • Maysan Centre for Diabetes and Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group
Newly diagnosed patients with T2DM, treated with non-pharmacological therapy (lifestyle modification).
Other: non-pharmacological therapy
non-pharmacological therapy (healthy lifestyle modifications)
Other Names:
  • control group
Active Comparator: Metformin only group
T2DM patients treated with metformin 500 mg/day in addition to non-pharmacological therapy (lifestyle modification)
Other: non-pharmacological therapy
non-pharmacological therapy (healthy lifestyle modifications)
Other Names:
  • control group
Drug: Metformin 500 mg/day
Metformin 500 mg/day in addition to non-pharmacological therapy
Other Names:
  • Metformin group
Experimental: Combination group
T2DM patients treated with metformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy (lifestyle modification)
Other: non-pharmacological therapy
non-pharmacological therapy (healthy lifestyle modifications)
Other Names:
  • control group
Drug: Metformin 500 mg/day
Metformin 500 mg/day in addition to non-pharmacological therapy
Other Names:
  • Metformin group
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 Names:
  • Combination group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline, to one month
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.
Change from baseline, to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline, to one month
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.
Change from baseline, to one month
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.
Change from baseline, to one month
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
Change from baseline, to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Rasheed University College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Actual)

June 26, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR200108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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