Evaluation of the Effect of Curcumin Administration on the Clinical Outcome of Diabetic Patients With Atherosclerotic Cardiovascular Risk
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Heart Rate
研究概览
简要总结
The aim of the study is to assess the safety and efficacy of Curcumin supplementation in combination to the conventional therapy in improving the clinical outcomes, oxidative stress and inflammation in diabetic patients with risk of ASCVD.
详细描述
Atherosclerotic cardiovascular disease (ASCVD) is one of the most devastating consequences of Diabetes Mellitus (DM), especially when combined with other comorbid conditions such as dyslipidemia and hypertension. To lessen the probability of ASCVD, modifying an individual's lifestyle and regulating one's lipid profile, blood pressure, and glucose levels are all beneficial approaches that decrease the risk of ASCVD occurrence. Numerous diseases, including hypertension, dyslipidemia, and diabetes mellitus, have been shown to be significantly influenced by both oxidative stress and inflammation. Curcumin is thought to regulate blood pressure, lipid profile, blood glucose levels. Moreover, It is claimed that curcumin can alleviate inflammation and oxidative stress. Curcumin is therefore suggested to have a beneficial role in lowering the risk of atherosclerotic cardiovascular diseases.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult Male or female patients aged 40 years or older
- •A calculated 10 year ASCVD risk score of 5 % or more
- •Patient previously or newly diagnosed with hypertension
- •Patient previously or newly diagnosed with dyslipidaemia
- •Patients diagnosed as Type 2 diabetes mellitus taking insulin or oral hypoglycemic agent with controlled HbA1c < 10%
- •Willingness and ability to give informed consent.
排除标准
- •Congenital or acquired bleeding disorders.
- •Cholelithiasis, gall bladder or biliary tract disease or other active liver diseases.
- •Pregnant or breastfeeding women.
- •Oral hypoglycemic drugs that affect cardiovascular diseases risk.
- •Patients with clinical ASCVD (myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease).
结局指标
主要结局
Heart Rate
时间窗: Change from Baseline Heart Rate at 14 weeks
Pulse in bpm
Lipid Profile
时间窗: Change from Baseline Lipid profile at 14 weeks
Serum sample to determine ( Triglyceride level , LDL ,HDL ,Total cholesterol ) in mg/dl
Blood Glucose Level
时间窗: Change from Baseline Blood Glucose Level at 14 weeks
Fasting blood glucose (FBG) in mg/dl , Hemoglobin A1c (HbA1c) in percentage
(Atherosclerotic cardiovascular diseases risk score) Low-risk (<5%) Borderline risk (5% to 7.4%) Intermediate risk (7.5% to 19.9%) High risk (≥20%)
时间窗: Change from Baseline ASCVD risk scoring at 14 weeks
10 year ASCVD risk calculation by using Pooled cohort equations
Blood Pressure
时间窗: Change from Baseline Blood Pressure at 14 weeks
(SBP and DBP) in mmHg by using Sphygmomanometer
次要结局
- Serum Ferritin(Change from Baseline Ferritin concentration at 14 weeks)
- Concentration of Tumor necrosis factor alpha ( TNF-alpha)(Change from Baseline TNF-alpha concentration at 14 weeks)
- Concentration of Malondialdehyde (MDA)(Change from Baseline MDA concentration at 14 weeks)
- International normalized ratio(Change from Baseline INR level at 14 weeks)
研究者
Omar El Rakabawy
Teaching Assistant
Ain Shams University