Antiatherogenic and Antimetabolic Effect of Curcumin in Type 2 Diabetic Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients
研究概览
简要总结
There are evidence that there is an association between insulin resistance and prolonged hyperinsulinemia or hyperglycemia in Type 2 diabetic patients. This will trigger oxidative stress system via reactive oxygen species (ROS) and lead to a high level of Nitric oxide. This can contribute to a significant change in blood vessel and could end up with the complications from cardiovascular disease and increased mortality rate of type 2 diabetic patients. The purpose of the present study was to examine the effectiveness of the curcumin in type 2 diabetic patients on the reduction of atherosclerosis events by examining pulse-wave velocity (PWV) and plasma high-sensitivity C-reactive protein (CRP) test and on blood sugar lowering, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patients aged 35 years or older and did not use insulin during the first 5 years of treatment after being diagnosed (with or without symptoms listed in the following inclusion criteria)
- •Patient with hyperlipidemia (Cholesterol ≥ 200 mg/dl, TG ≥ 150 mg/dl, LDL ≥ 100 mg/dl and HDL ≥ 35 mg/dl)
- •Patient with hypertension (Blood pressure ≥ 130/85 mmHg or take hypertensive drugs)
- •Obesity (BMI ≥ 25)
排除标准
- •Current diagnosis of secondary peripheral arterial disease (PAD) (except listed in the inclusion criteria item 1-4)
- •Current diagnosis of cardiovascular disease, i.e., coronary arterial disease and cerebrovascular disease
- •Current diagnosis of end stage renal function with serum creatinine > 2.0 mg/dl or on renal dialysis
- •Current diagnosis of cirrhosis with ALT ≥ 3 times of normal range
研究组 & 干预措施
Placebo
干预措施: curcumin (Drug)
Curcumin
干预措施: curcumin (Drug)
结局指标
主要结局
to determine the effectiveness of curcumin on reduction of atherosclerotic events and risks in Type 2 diabetic patients
时间窗: 12 months
次要结局
- To examine the effectiveness of curcumin on the reduction of blood sugar, glycosylated hemoglobin (HBA1c), lipid profile, and insulin resistance(12 months)