Trial record 14 of 23 for:    Cardiomyopathy | Open Studies | NIH, U.S. Fed

Lipid Biomarkers for Diabetic Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 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: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Type II Diabetes Mellitus
Diabetes Complications
Drug: Fenofibrate
Drug: Placebo for fenofibrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Lipid Biomarkers for Diabetic Heart Disease

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in cardiac function as measured by fractional shortening percent [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: March 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenofibrate
One fenofibrate 160 mg capsule per day for 12 weeks
Drug: Fenofibrate
Other Names:
  • Tricor
  • Triglide
  • Antara
  • Lipofen
Placebo Comparator: Placebo for fenofibrate
One inert sugar pill per day for 12 weeks
Drug: Placebo for fenofibrate
Other Name: Sugar pill manufactured to mimic Fenofibrate 160 mg capsule

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • triglycerides > 150 mg/dL

Exclusion Criteria:

  • body weight > 300 lb.
  • HIV
  • hypothyroid
  • steroid medication, beta blocker, Ca++ channel blocker, fenofibrate
  • smoking
  • BP > 140/90
  • heart disease
  • pregnant or lactating
  • consumption of > 5 alcoholic drinks/wk
  • creatinine > 1.5 mg/dL
  • hematocrit < 28
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752842

Contacts
Contact: Marsha S Farmer, MS 314-747-3357 mfarmer@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Marsha S Farmer, MS    314-747-3357    mfarmer@dom.wustl.edu   
Principal Investigator: Jean E Schaffer, MD         
Sponsors and Collaborators
Washington University School of Medicine
Leducq Foundation
Investigators
Principal Investigator: Jean E Schaffer, MD Washington University School of Medicine
  More Information

Publications:
Griffin JA, Osborn BW, Smithline HA. The impact of diabetes on hospital admissions, length of stay and mortality in emergency department patients with acute decompensated heart failure without ischemia. Acad Emerg Med. 2005;12:s97

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01752842     History of Changes
Other Study ID Numbers: 201112122, P20HL113444-01
Study First Received: December 14, 2012
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Diabetes
Diabetic Cardiomyopathy
Triglycerides

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014