NCT00704314已完成不适用
Effects of High Dose Simvastatin Therapy on Glucose Metabolism and Ectopic Lipid Deposition in Non-Obese Type 2 Diabetic Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- insulin sensitivity
研究概览
简要总结
We aimed to address the issue whether statins affect insulin resistance. To this end, we combined the available state-of-the art technology for detailed assessment of both whole-body and tissue specific insulin sensitivity in vivo in humans (euglycemic-hyperinsulinemic clamp, stable isotope [6,6-2H2]glucose dilution technique, proton nuclear magnetic resonance spectroscopy - 1H MRS - of liver and skeletal muscle). Outcome measures were determined before and after 8 weeks therapy with 80 mg Simvastatin in hypercholesterolemic patients with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients with known duration of disease: 3-10 years
- •Age: 35-75 years
- •BMI<32 kg/m2
- •Hypercholesterolemia: fasting serum low density lipoprotein (LDL)
- •Cholesterol concentration < 4.16 mmol/L (<160 mg/dl)
- •Normotriglyceridemia: fasting plasma triglyceride concentration < 2.75 mmol/L (250 mg/dl)
- •Creatinine levels < 1.8 mg /dl
- •Liver transaminases < 20% over the upper limit with no active liver disease and CK < 50% above the upper limit
- •Blood pressure less than 160/100 mmHg were accepted as eligible for enrollment
排除标准
- •Hypertension, cardiovascular disease or metabolic diseases other than T2DM as determined by medical history, physical examination and routine laboratory tests
- •Alcohol consumption (more than 10 drinks/week)
- •Poor glycemic control (HbA1c<9%)
- •Patients requiring insulin, patients with type 1 diabetes
- •Patients taking any medicine known to interfere with metabolism of statins or with insulin sensitivity as summarized in an exclusionary drug table
- •Patients receiving any hypolipidemic medication or diet during the last 2 months before enrollment
研究组 & 干预措施
1
Active Comparator
Simvastatin therapy, 80 mg/d for 8 weeks
干预措施: Simvastatin (Drug)
2
Placebo Comparator
Placebo, one pill daily for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
insulin sensitivity
时间窗: 8 weeks
次要结局
- ectopic lipid deposition in liver and muscle(8 weeks)
研究者
研究点 (1)
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