Pyridoxine Effect on the Blood Glucose Level in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

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.
    

Intervention name(s): Metformin 500 mg/day; Metformin 500 mg/day plus vitamin B6 300 mg/day; non-pharmacological therapy
Intervention type(s): Drug; Combination Product; Other
Intervention description(s): Metformin 500 mg/day in addition to non-pharmacological therapy; Metformin 500 mg/day plus vitamin B6 300 mg/day in addition to non-pharmacological therapy; non-pharmacological therapy (healthy lifestyle modifications)
Other intervention name(s): Metformin group; Combination group; control group
Intervention MeSH terms: Vitamin B 6; Pyridoxal; Pyridoxine; Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment