Lipid Biomarkers for Diabetic Heart Disease
Condition: Type II Diabetes Mellitus; Diabetes Complications
MeSH terms: Heart Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
Study type: Interventional

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Fenofibrate; Placebo for fenofibrate
Intervention type(s): Drug; Drug
Other intervention name(s): Tricor; Triglide; Antara; Lipofen; Sugar pill manufactured to mimic Fenofibrate 160 mg capsule
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Diabetic Cardiomyopathy; Triglycerides