Lipid Biomarkers for Diabetic Heart Disease

The Washington University

Status: Completed

Conditions: Diabetes Complications; Type II Diabetes Mellitus

Treatments: Drug: Placebo for fenofibrate; Drug: Fenofibrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01752842

201112122

P20HL113444-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus

Exclusion criteria

• body weight > 300 lb.
• HIV
• hypothyroid
• steroid medication, fenofibrate
• smoking
• BP > 140/90
• heart disease
• pregnant or lactating
• consumption of > 5 alcoholic drinks/wk
• creatinine > 1.5 mg/dL
• hematocrit < 28

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Fenofibrate

Experimental group

Description:

One fenofibrate 160 mg capsule per day for 12 weeks

Treatment:

Drug: Fenofibrate

Placebo for fenofibrate

Placebo Comparator group

Description:

One inert sugar pill per day for 12 weeks

Treatment:

Drug: Placebo for fenofibrate