Effect of a Fibrate (Fenofibrate) and a Statin (Atorvastatin) and on Endothelial Dysfunction in Diabetes Mellitus and the Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Brachial Artery Flow-mediated Dilation
研究概览
简要总结
The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome.
详细描述
The study will compare the effect of atorvastatin to the effect of fenofibrate on endothelial function in patients with diabetes mellitus or the metabolic syndrome. The study is a double blind, placebo controlled, crossover study with the order of treatment randomized. Patients will receive each treatment for 8 weeks with a 1 week rest period between treatment periods. Endothelial function will be tested using non-invasive techniques before and after each treatments. A total of 40 subjects with diabetes or the metabolic syndrome will be enrolled at Boston Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 30 years
- •Adult-onset DM (defined as fasting glucose greater than 125 mg/dl or by ongoing treatment with an oral hypoglycemic agent) or metabolic syndrome (defined as at least 3 of the following:
- •HDL less than 40 mg/dl for men or less than 50 mg/dl for women;
- •triglycerides greater than 150 mg/dl;
- •waist circumference greater than 40 inches for men and greater than 35 inches for women;
- •fasting glucose greater than 100 mg/dl).
- •LDL cholesterol level less than 140 mg/dl
- •Able to provide informed consent and complete study procedures
排除标准
- •Change in therapy for glucose control or blood pressure less than 1 month before entry
- •Hemoglobin A1C greater than 8.0%.
- •Renal insufficiency (serum creatinine greater than 1.6 mg/dl in men or 1.5 mg/dl in women.
- •Any investigational drug less than 1 month before entry.
- •Pregnancy (excluded by urine pregnancy test at study entry with ongoing use of reliable form of birth control) or lactation
- •Liver function tests or serum creatinine kinase (CK) greater than 3 times upper limit of normal.
- •Clinically evident major illnesses or other problem that would make participation inappropriate
- •Clinical history of symptomatic cholelithiasis
- •Patients with coronary artery disease, peripheral arterial disease, or cerebral vascular disease will not be enrolled if they are currently taking lipid-lowering therapy
- •Patients taking more than 40 mg/day of atorvastatin will be excluded. There is no "ceiling" level for patients taking fibrates.
研究组 & 干预措施
Fenofibrate First
Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second
干预措施: Fenofibrate (Drug)
Fenofibrate First
Fenofibrate 145 mg/day for 8 weeks First and Atorvastatin 20 mg/day for 8 weeks Second
干预措施: Atorvastatin (Drug)
Atorvastatin First
Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second
干预措施: Fenofibrate (Drug)
Atorvastatin First
Atorvastatin 20 mg/day for 8 weeks First and Fenofibrate 145 mg/day for 8 weeks Second
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Brachial Artery Flow-mediated Dilation
时间窗: 8 weeks
Endothelial function was assessed as brachial artery flow-mediated dilation (FMD) using ultrasound. FMD is calculated as the difference in brachial diameter during hyperemic flow and brachial diameter at baseline divided by brachial diameter at baseline and expressed as percent dilation.
次要结局
- Serum Lipids(8 weeks)
研究者
Joseph A. Vita
Professor of Medicine
Boston University