Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function"

Phase 2

Completed

• Conditions: Heart Failure; Diabetes
• Interventions: Other: metabolic substrate modulation

• Registration Number: NCT01192373
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-30
• Study Start: 2010-09
• Study First Posted: 2010-09-01
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• ejection fraction at or lower than 45%
• type 2 diabetes

Exclusion Criteria

• known s-creatinine >220mM
• known S-alanine aminotransferase >3 times normal upper limit
• other disabilitating conditions
• pregnancy
• insulin treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low circulation free fatty acids	metabolic substrate modulation	using hyperinsulinaemic euglycemic clamp for 8 hours
High circulating free fatty acids	metabolic substrate modulation	using Heparin af intralipid infusion for 8 hours

Primary Outcome Measures

Name	Time	Method
Left ventricular function	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	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	1-6 weeks	Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.

Secondary Outcome Measures

Name	Time	Method
Regional left ventricular function	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	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	1-6 weeks	bloodsamples

Trial Locations

Locations (1)

Dept. of cardiology, Aarhus University hospital Skejby,; 🇩🇰 Aarhus, Region Midjylland, Denmark