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Lipid Biomarkers for Diabetic Heart Disease

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ClinicalTrials.gov Identifier: NCT01752842
Recruitment Status : Active, not recruiting
First Posted : December 19, 2012
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Leducq Foundation
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Diabetes Complications Drug: Fenofibrate Drug: Placebo for fenofibrate Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Lipid Biomarkers for Diabetic Heart Disease
Study Start Date : March 2013
Actual Primary Completion Date : February 28, 2018
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Fenofibrate
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in cardiac function as measured by fractional shortening percent [ Time Frame: Baseline and 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752842


Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Leducq Foundation
Investigators
Principal Investigator: Jean E Schaffer, MD Washington University School of Medicine

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01752842     History of Changes
Other Study ID Numbers: 201112122
P20HL113444-01 ( U.S. NIH Grant/Contract )
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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