Lipid Biomarkers for Diabetic Heart Disease
Primary Purpose
Type II Diabetes Mellitus, Diabetes Complications
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fenofibrate
Placebo for fenofibrate
Sponsored by
About this trial
This is an interventional treatment trial for Type II Diabetes Mellitus focused on measuring Diabetes, Diabetic Cardiomyopathy, Triglycerides
Eligibility 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fenofibrate
Placebo for fenofibrate
Arm Description
One fenofibrate 160 mg capsule per day for 12 weeks
One inert sugar pill per day for 12 weeks
Outcomes
Primary Outcome Measures
Change in Cardiac Diastolic Function as Measured by E' (cm/s)
Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.
Change in Cardiac Systolic Function as Measured by Fractional Shortening Percent
Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.
Secondary Outcome Measures
Change in C24:0/C16:0 Ceramide Ratio
Mass spectrometry-based quantification of the ratio of C24:0 ceramide to C16:0 ceramide in plasma.
Full Information
NCT ID
NCT01752842
First Posted
December 14, 2012
Last Updated
February 26, 2019
Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Leducq Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01752842
Brief Title
Lipid Biomarkers for Diabetic Heart Disease
Official Title
Lipid Biomarkers for Diabetic Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), Leducq Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes Mellitus, Diabetes Complications
Keywords
Diabetes, Diabetic Cardiomyopathy, Triglycerides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenofibrate
Arm Type
Experimental
Arm Description
One fenofibrate 160 mg capsule per day for 12 weeks
Arm Title
Placebo for fenofibrate
Arm Type
Placebo Comparator
Arm Description
One inert sugar pill per day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Other Intervention Name(s)
Tricor, Triglide, Antara, Lipofen
Intervention Type
Drug
Intervention Name(s)
Placebo for fenofibrate
Other Intervention Name(s)
Sugar pill manufactured to mimic Fenofibrate 160 mg capsule
Primary Outcome Measure Information:
Title
Change in Cardiac Diastolic Function as Measured by E' (cm/s)
Description
Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.
Time Frame
Baseline and 12 weeks
Title
Change in Cardiac Systolic Function as Measured by Fractional Shortening Percent
Description
Change was measured by echocardiography and was calculated as the value at 12 weeks minus the value at baseline.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in C24:0/C16:0 Ceramide Ratio
Description
Mass spectrometry-based quantification of the ratio of C24:0 ceramide to C16:0 ceramide in plasma.
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean E Schaffer, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
4835750
Citation
Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
Results Reference
background
PubMed Identifier
4278055
Citation
Hamby RI, Zoneraich S, Sherman L. Diabetic cardiomyopathy. JAMA. 1974 Sep 23;229(13):1749-54. No abstract available.
Results Reference
background
PubMed Identifier
15123530
Citation
Peterson LR, Herrero P, Schechtman KB, Racette SB, Waggoner AD, Kisrieva-Ware Z, Dence C, Klein S, Marsala J, Meyer T, Gropler RJ. Effect of obesity and insulin resistance on myocardial substrate metabolism and efficiency in young women. Circulation. 2004 May 11;109(18):2191-6. doi: 10.1161/01.CIR.0000127959.28627.F8. Epub 2004 May 3.
Results Reference
background
PubMed Identifier
16458143
Citation
Herrero P, Peterson LR, McGill JB, Matthew S, Lesniak D, Dence C, Gropler RJ. Increased myocardial fatty acid metabolism in patients with type 1 diabetes mellitus. J Am Coll Cardiol. 2006 Feb 7;47(3):598-604. doi: 10.1016/j.jacc.2005.09.030. Epub 2006 Jan 18.
Results Reference
background
PubMed Identifier
12594743
Citation
Szczepaniak LS, Dobbins RL, Metzger GJ, Sartoni-D'Ambrosia G, Arbique D, Vongpatanasin W, Unger R, Victor RG. Myocardial triglycerides and systolic function in humans: in vivo evaluation by localized proton spectroscopy and cardiac imaging. Magn Reson Med. 2003 Mar;49(3):417-23. doi: 10.1002/mrm.10372.
Results Reference
background
PubMed Identifier
15522914
Citation
Sharma S, Adrogue JV, Golfman L, Uray I, Lemm J, Youker K, Noon GP, Frazier OH, Taegtmeyer H. Intramyocardial lipid accumulation in the failing human heart resembles the lipotoxic rat heart. FASEB J. 2004 Nov;18(14):1692-700. doi: 10.1096/fj.04-2263com.
Results Reference
background
Citation
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
Results Reference
background
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Lipid Biomarkers for Diabetic Heart Disease
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