NCT01752842|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
interventional
70
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 23, 2018
Actual (reported)Study Completion
February 23, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 23, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 14, 2012
Actual (reported)December 19, 2012
Actual (reported)March 2013
Date type not reportedThis date has not been verified as actual or estimated.
February 23, 2018
Actual (reported)February 23, 2018
Actual (reported)February 26, 2019
Actual (reported)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
Change in C24:0/C16:0 Ceramide Ratio
Baseline and 12 weeks
One fenofibrate 160 mg capsule per day for 12 weeks
One inert sugar pill per day for 12 weeks
Washington University School of Medicine
St Louis, Missouri, 63110, United States
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.
Hamby RI, Zoneraich S, Sherman L. Diabetic cardiomyopathy. JAMA. 1974 Sep 23;229(13):1749-54. No abstract available.
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.
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.
Jean E Schaffer, MD
Washington University School of Medicine
70 participants (actual enrollment reported by the registry).
First Submitted
December 14, 2012
First Posted
December 19, 2012
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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.
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
Primary Completion
February 23, 2018
Actual (reported)Study Completion
February 23, 2018
Actual (reported)Last Updated
March 15, 2019
Results First Posted
February 26, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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