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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05918068
• Other study ID #: AR200108
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: May 2023
• Source: Al-Rasheed University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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)

Locations

Country	Name	City	State
Iraq	Maysan Centre for Diabetes and Endocrinology	Maysan Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Al-Rasheed University College

Country where clinical trial is conducted

Iraq, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Vitamin B6	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
Secondary	Fasting plasma insulin (F.P.I.).	The insulin fasting blood test is chiefly used to test insulin levels and diagnose diabetes and insulin resistance.	Change from baseline, to one month
Secondary	Insulin resistance (HOMA-IR).	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
Secondary	Indoleamine 2,3 dioxygenase (IDO)	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