Effect of Vitamin C Adjuant Therapy on Lipid Profile in Diabetic Patients with Co-morbid Cardiovascular Disease
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Evaluation of effet of Vitamin C Adjuant therapy significance on lipid profile and HbA1c in diabetes patients with co-morbid cardiovascular disease.
研究概览
简要总结
Patients with diabetes mellitus have 2 to 4 fold increase in the prevalence of cardiovascular disease compared to non-diabetes mellitus due to rise in blood glucose and serum cholesterol levels. Vitamin C plays important role in prevention of diabetic complications by scavenging free radicals and thus preventing the initiation of chain reactions that leads to protein glycation and protecting against lipid peroxidation.Vitamin C is structurally similar to glucose and can replace it in many chemical reactions and thus is effective for prevention of non-enzymatic glycation of protein. Vitamin C as an antioxidant can probably reduce insulin resistance by improved endothelial function and lowering oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •patients diagnosed with type 2 diabetes mellitus for a period of not less than 2 years with co-morbid cardiovascular disease (new onset/past history), whose blood sugar profile is uncontrolled as indicated by HbA1c above 8.0, in treatment with the standard treatment regimen for diabetes mellitus as per the recommended guidelines and willing to provide written informed consent.
排除标准
- •1.Patients with concomitant life threatening illness, including myocardial infarction, ischemic stroke or risk of developing NSTEMI, STEMI.
- •2.Patients with metabolic acidosis 3.Patients who had a history of renal calculi.
结局指标
主要结局
Evaluation of effet of Vitamin C Adjuant therapy significance on lipid profile and HbA1c in diabetes patients with co-morbid cardiovascular disease.
时间窗: Baseline, 1st month, 2nd month and 3rd month.
次要结局
- Adjustment for factors those confounds the effect of vitamin therapy on lipid profile and thereby quantify the extent of the effect(Baseline, 1st month, 2nd month and 3rd month.)
- Evaluation of Incidence of elevated CRP levels in diabetic patients with dislipidemia(Baseline, 1st month, 2nd month and 3rd month.)
- Assessement of the acute effect of Vitamin C adjuant therapy on serum C-reactive protein.(Baseline, 1st month, 2nd month and 3rd month.)