Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function" (Metamod3)
|ClinicalTrials.gov Identifier: NCT01192373|
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : January 21, 2013
The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes.
Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure Diabetes||Other: Metabolic substrate modulation Other: metabolic substrate modulation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Short Term Modulation of Circulating Free Fatty Acids in Heart Failure Patients With Type 2 Diabetes: "Effect on Myocardial Lipid Content, Left Ventricular Function and Exercise Capacity"|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2012|
Experimental: High circulating free fatty acids
using Heparin af intralipid infusion for 8 hours
Other: Metabolic substrate modulation
for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
Active Comparator: Low circulation free fatty acids
using hyperinsulinaemic euglycemic clamp for 8 hours
Other: metabolic substrate modulation
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
- Left ventricular function [ Time Frame: 1-6 weeks ]
Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate).
Left ventricular diastolic funtion (E/A ratio, E/e' ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids.
- intracellular lipid content [ Time Frame: 1-6 weeks ]
Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content).
Outcome is difference between low and high ciculating free fatty acids.
- Exercise capacity and oxygen consumption [ Time Frame: 1-6 weeks ]Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.
- Regional left ventricular function [ Time Frame: 1-6 weeks ]regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids.
- 6 minutes hall walk test [ Time Frame: 1-6 weeks ]distance difference between low and high levels of circulating FFA. Outcome is difference between low and high ciculating free fatty acids.
- metabolic and hormonal profile [ Time Frame: 1-6 weeks ]bloodsamples
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192373
|Dept. of cardiology, Aarhus University hospital Skejby,|
|Aarhus, Region Midjylland, Denmark, 8200|
|Principal Investigator:||Roni R Nielsen, MD||Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark|