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

This study has been completed.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01192373
First received: August 24, 2010
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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
Diabetes
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 ]
    bloodsamples


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.

  Eligibility

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01192373

Locations
Denmark
Dept. of cardiology, Aarhus University hospital Skejby,
Aarhus, Region Midjylland, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Danish Heart Foundation
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov 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:
Heart Failure
Diabetes Mellitus
Heart Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014