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临床试验/NCT05918068
NCT05918068已完成不适用

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

Al-Rasheed University College1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
Glycated Hemoglobin (HbAlc)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

研究组 & 干预措施

Control group

Other

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

干预措施: non-pharmacological therapy (Other)

Metformin only group

Active Comparator

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

干预措施: Metformin 500 mg/day (Drug)

Metformin only group

Active Comparator

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

干预措施: non-pharmacological therapy (Other)

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)

干预措施: Metformin 500 mg/day (Drug)

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)

干预措施: Metformin 500 mg/day plus vitamin B6 300 mg/day (Combination Product)

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)

干预措施: non-pharmacological therapy (Other)

结局指标

主要结局

Glycated Hemoglobin (HbAlc)

时间窗: 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.

Fasting plasma glucose (FPG).

时间窗: 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

次要结局

  • 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)

研究者

发起方
Al-Rasheed University College
申办方类型
Other
责任方
Sponsor

研究点 (1)

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