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Completed

NCT Number: NCT01192373

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dept. of cardiology, Aarhus University hospital Skejby,

Aarhus, Region Midjylland, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metabolic substrate modulation

Other

for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Danish Heart Foundation

Registry information

Official study 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"

Acronym: Metamod3

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 1, 2010
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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