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

Phase 2CompletedNCT01192373

University of Aarhus18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Heart Failure Diabetes

Interventions

Metabolic substrate modulationOTHER

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

metabolic substrate modulationOTHER

low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Dept. of cardiology, Aarhus University hospital Skejby,

Aarhus, Region Midjylland, Denmark

Outcomes

Primary Outcomes

Left ventricular function

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.

Time frame: 1-6 weeks

intracellular lipid content

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.

Time frame: 1-6 weeks

Exercise capacity and oxygen consumption

Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.

Time frame: 1-6 weeks

Secondary Outcomes

Regional left ventricular function

regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids.

Time frame: 1-6 weeks

6 minutes hall walk test

distance difference between low and high levels of circulating FFA. Outcome is difference between low and high ciculating free fatty acids.

Time frame: 1-6 weeks

metabolic and hormonal profile

bloodsamples

Time frame: 1-6 weeks

Data from ClinicalTrials.gov

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