Impact of Vitamin C and E Supplementation on Glycemic Control in Adults with Type 2 Diabetes Mellitus Receiving Standard Treatment: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the change in glycemic control and insulin resistance from baseline to 12 weeks
研究概览
简要总结
The study investigates whether supplementing standard treatment with vitamins C and E can improve glycemic control in adults with type 2 diabetes mellitus (T2DM). It uses a 12-week, randomized clinical trial design with participants divided into two groups: one receiving vitamins C and E alongside standard therapy (e.g., metformin) and the other receiving standard therapy alone.
The primary goal is to assess improvements in glycemic parameters, while secondary goals include evaluating insulin sensitivity and overall health. The study aims to identify the potential benefits of antioxidant supplementation as an adjunct to standard diabetes treatment, with the ultimate goal of informing strategies to reduce complications and improve outcomes in adults with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •T2DM patients receiving standard antidiabetic medication.
- •Willing and able to provide informed consent.
排除标准
- •Type 1 Diabetes Mellitus patients.
- •Diabetic complications, such as: retinopathy, nephropathy, neuropathy, ketoacidosis, or hyperosmolar state Pregnant or lactating women.
结局指标
主要结局
To evaluate the change in glycemic control and insulin resistance from baseline to 12 weeks
时间窗: Baseline (week 0), Weeks 4,8 and 12
次要结局
- To evaluate the adverse effects and tolerability of vitamin C and E supplementation in type 2 diabetic patients.(To assess the effect of vitamin C and E supplementation on blood pressure in type 2 diabetic patients.)
研究者
Dr Aneesh Basheer
SRMMCHRC, SRMIST