Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Change in High-sensitivity C-reactive Protein
研究概览
简要总结
The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.
详细描述
Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference >40inches in men, >35 inches in women elevated triglycerides >150mg/dL reduced HDL <40mg/dL in men<50 in women elevated blood pressure >130mmHg systolic, or >85mmHg diastolic elevated fasting glucose >100mg/dL
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-75 years
- •Metabolic syndrome (3 of the 5 components)
- •Elevated waist circumference >40inches in men, >35inches in women
- •Elevated triglycerides >150mg/dL
- •Reduced HDL <40mg/dL in men, <50mg/dL in women
- •Elevated blood pressure >130mmHg systolic, >85mmHg diastolic
- •Elevated fasting glucose >100mg/dL
排除标准
- •Diabetes mellitus
- •Stage 3 hypertension >180mmHg systolic, >110mmHg diastolic office blood pressure
- •History of non-diabetic kidney disease
- •Myocardial infarction of unstable angina within the past 6 months
- •History of liver disease
- •History of malignancy
- •History of drug or alcohol abuse
- •Treatment with corticosteroids
- •Pregnancy or lactating women of women of child bearing potential who are not willing to use reliable contraception method during the study
研究组 & 干预措施
Simvastatin + Placebo Rosiglitazone
Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily
干预措施: Placebo Rosiglitazone (Drug)
Simvastatin + Placebo Rosiglitazone
Subjects will receive 40 mg Simvastatin + 1 tab Placebo Rosiglitazone daily
干预措施: Simvastatin (Drug)
Simvastatin + rosiglitazone
Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily
干预措施: Rosiglitazone (Drug)
Simvastatin + rosiglitazone
Subjects will receive 40 mg Simvastatin + 4 mg Rosiglitazone once daily
干预措施: Simvastatin (Drug)
结局指标
主要结局
Change in High-sensitivity C-reactive Protein
时间窗: Baseline and 6 months
change in high-sensitivity C-reactive between baseline and 6 month
次要结局
- Change in Malondialdehyde(Baseline and 6 months)
- Change in Office Diastolic Blood Pressure(Baseline and 6 months)
- Change in Urinary Isoprostane(Baseline and 6 months)
- Change in Office Systolic Blood Pressure(Baseline and 6 months)
- Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure(Baseline and 6 months)
- Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure(Baseline and 6 months)
- Change in Low-density Lipoprotein(Baseline and 6 months)
- Change in Triglycerides(Baseline and 6 months)
- Change in Glycosylated Haemoglobin(Baseline and 6 months)
- Change in Fasting Blood Glucose(Baseline and 6 months)
- Change in Insulin(Baseline and 6 months)
- Change in Homeostatic Model Assessment for Insulin Resistance(Baseline and 6 months)
- Change in High-density Lipoprotein(Baseline and 6 months)
- Change in Adiponectin(Baseline and 6 months)
- Change in Body Mass Index(Baseline and 6 months)