Lipid Biomarkers for Diabetic Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
Leducq Foundation
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01752842
First received: December 14, 2012
Last updated: August 29, 2014
Last verified: August 2014

December 14, 2012
August 29, 2014
March 2013
March 2017   (final data collection date for primary outcome measure)
Change in cardiac function as measured by fractional shortening percent [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01752842 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lipid Biomarkers for Diabetic Heart Disease
Lipid Biomarkers for Diabetic Heart Disease

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type II Diabetes Mellitus
  • Diabetes Complications
  • Drug: Fenofibrate
    Other Names:
    • Tricor
    • Triglide
    • Antara
    • Lipofen
  • Drug: Placebo for fenofibrate
    Other Name: Sugar pill manufactured to mimic Fenofibrate 160 mg capsule
  • Experimental: Fenofibrate
    One fenofibrate 160 mg capsule per day for 12 weeks
    Intervention: Drug: Fenofibrate
  • Placebo Comparator: Placebo for fenofibrate
    One inert sugar pill per day for 12 weeks
    Intervention: Drug: Placebo for fenofibrate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
104
March 2017
March 2017   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
No
Contact: Marsha S Farmer, MS 314-747-3357 mfarmer@dom.wustl.edu
United States
 
NCT01752842
201112122, P20HL113444-01
Yes
Washington University School of Medicine
Washington University School of Medicine
  • National Institutes of Health (NIH)
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Leducq Foundation
Principal Investigator: Jean E Schaffer, MD Washington University School of Medicine
Washington University School of Medicine
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP