Lipid Biomarkers for Diabetic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Cardiac Diastolic Function as Measured by E' (cm/s)
研究概览
简要总结
This study will test whether lowering the delivery of excess fats to the heart in persons with type-2 diabetes mellitus improves heart muscle function. The investigators will also test whether specific lipid molecular species in plasma can serve as biomarkers for diabetic heart disease.
详细描述
Screening procedures include 12-hour fasting blood draw, urine pregnancy testing for females, completion of medical history questionnaire, and stress echocardiography to rule out coronary artery disease or cardiomyopathy.
Subjects who meet screening criteria will return for visit 2, which consists of a urine collection, 12-hour fasting blood draw, dual-energy X-ray absorptiometry (DXA) for body composition, magnetic resonance spectroscopy analysis of the liver, and resting echocardiogram for analysis of heart structure and function. Subjects will then be randomized to treatment with fenofibrate (160 mg/d) or an identical-appearing placebo for 12 weeks. They will be asked to continue their usual medications, diet and physical activity. Subjects will receive a pedometer to wear daily to track their physical activity. Subjects will meet with dietitians from the Lifestyle Intervention Core to complete a 24-hour dietary recall. They will be instructed to record their daily blood glucose concentrations, distance walked and any side effects, illnesses or stresses in a study-supplied log. Subjects will be instructed to either email or fax the log to the study coordinator each week (or discuss by phone).
Subjects will return 6 weeks after starting intervention for visit 3 to ensure their medical safety. Procedures at this visit include an interim medical history, urine pregnancy test for females, blood draw to rule out untoward effects of the study drug on liver or kidney function, pill count to assess compliance, review of logs of blood glucose, distance walked, and side effects, illnesses or stresses, and meeting with a dietitian for a 24-hour dietary recall.
Subjects will continue to take their study medication/placebo and keep logs of blood glucose levels, distance walked, and side effects, illnesses and stresses for another 6 weeks. They will return for visit 4 after 12 total weeks of intervention. Visit 4 involves a urine collection, 12-hour fasting blood draw, review of subject logs, pill count, and 24-hour dietary recall. In addition, magnetic resonance spectroscopy analysis of the liver and resting echocardiogram analysis of the heart will be performed to determine if there have been any changes in liver fat or heart function during the 12-week intervention.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus
排除标准
- •body weight > 300 lb.
- •hypothyroid
- •steroid medication, fenofibrate
- •BP > 140/90
- •heart disease
- •pregnant or lactating
- •consumption of > 5 alcoholic drinks/wk
- •creatinine > 1.5 mg/dL
- •hematocrit < 28
研究组 & 干预措施
Fenofibrate
One fenofibrate 160 mg capsule per day for 12 weeks
干预措施: Fenofibrate (Drug)
Placebo for fenofibrate
One inert sugar pill per day for 12 weeks
干预措施: Placebo for fenofibrate (Drug)
结局指标
主要结局
Change in Cardiac Diastolic Function as Measured by E' (cm/s)
时间窗: Baseline and 12 weeks
Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.
Change in Cardiac Systolic Function as Measured by Fractional Shortening Percent
时间窗: Baseline and 12 weeks
Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.
次要结局
- Change in C24:0/C16:0 Ceramide Ratio(Baseline and 12 weeks)