Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function" (Metamod3)

This study has been completed.
Danish Heart Foundation
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: August 24, 2010
Last updated: January 18, 2013
Last verified: January 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 Intervention Phase
Heart Failure
Other: Metabolic substrate modulation
Other: metabolic substrate modulation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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"

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Left ventricular function [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.

Secondary Outcome Measures:
  • Regional left ventricular function [ Time Frame: 1-6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01192373

Dept. of cardiology, Aarhus University hospital Skejby,
Aarhus, Region Midjylland, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Danish Heart Foundation
Principal Investigator: Roni R Nielsen, MD Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT01192373     History of Changes
Other Study ID Numbers: M20090230
Study First Received: August 24, 2010
Last Updated: January 18, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases processed this record on April 16, 2014