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

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ClinicalTrials.gov Identifier: NCT01192373
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : January 21, 2013
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
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.


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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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"
Study Start Date : September 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. metabolic and hormonal profile [ Time Frame: 1-6 weeks ]
    bloodsamples



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Heart Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases