Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"
NCT ID: NCT01192373
Last Updated: 2013-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
18 participants
INTERVENTIONAL
2010-09-30
2012-03-31
Brief Summary
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Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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High circulating free fatty acids
using Heparin af intralipid infusion for 8 hours
Metabolic substrate modulation
for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
Low circulation free fatty acids
using hyperinsulinaemic euglycemic clamp for 8 hours
metabolic substrate modulation
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
Interventions
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Metabolic substrate modulation
for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
metabolic substrate modulation
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
Eligibility Criteria
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Inclusion Criteria
* type 2 diabetes
Exclusion Criteria
* known S-alanine aminotransferase \>3 times normal upper limit
* other disabilitating conditions
* pregnancy
* insulin treatment
30 Years
85 Years
ALL
No
Sponsors
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Danish Heart Foundation
OTHER
University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Roni R Nielsen, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
Locations
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Dept. of cardiology, Aarhus University hospital Skejby,
Aarhus, Region Midjylland, Denmark
Countries
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References
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Nielsen R, Norrelund H, Kampmann U, Kim WY, Ringgaard S, Schar M, Moller N, Botker HE, Wiggers H. Failing heart of patients with type 2 diabetes mellitus can adapt to extreme short-term increases in circulating lipids and does not display features of acute myocardial lipotoxicity. Circ Heart Fail. 2013 Jul;6(4):845-52. doi: 10.1161/CIRCHEARTFAILURE.113.000187. Epub 2013 Jun 3.
Other Identifiers
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M20090230
Identifier Type: -
Identifier Source: org_study_id
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