Lipid Biomarkers for Diabetic Heart Disease
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2012
CompletedFirst Posted
Study publicly available on registry
December 19, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2018
CompletedResults Posted
Study results publicly available
February 26, 2019
CompletedMarch 15, 2019
February 1, 2019
5 years
December 14, 2012
February 7, 2019
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
Secondary Outcomes (1)
Change in C24:0/C16:0 Ceramide Ratio
Baseline and 12 weeks
Study Arms (2)
Fenofibrate
EXPERIMENTALOne fenofibrate 160 mg capsule per day for 12 weeks
Placebo for fenofibrate
PLACEBO COMPARATOROne inert sugar pill per day for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- National Institutes of Health (NIH)collaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Leducq Foundationcollaborator
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Publications (7)
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.
PMID: 4835750BACKGROUNDHamby RI, Zoneraich S, Sherman L. Diabetic cardiomyopathy. JAMA. 1974 Sep 23;229(13):1749-54. No abstract available.
PMID: 4278055BACKGROUNDPeterson 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.
PMID: 15123530BACKGROUNDHerrero 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.
PMID: 16458143BACKGROUNDSzczepaniak 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.
PMID: 12594743BACKGROUNDSharma 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.
PMID: 15522914BACKGROUNDGriffin 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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Findings of this study cannot be extended to those who do not fit the entry criteria. Also, since this was a targeted lipidomics study, there may be changes in other lipid species after treatment with fenofibrate that were not analyzed.
Results Point of Contact
- Title
- Jean E. Schaffer, MD
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Jean E Schaffer, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2012
First Posted
December 19, 2012
Study Start
March 1, 2013
Primary Completion
February 23, 2018
Study Completion
February 23, 2018
Last Updated
March 15, 2019
Results First Posted
February 26, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share