Diabetes, Heart Failure
Conditions
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.
Interventions
OTHERMetabolic substrate modulation
for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
OTHERmetabolic substrate modulation
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
Sponsors
Danish Heart Foundation
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left ventricular function | 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. |
| intracellular lipid content | 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. |
| Exercise capacity and oxygen consumption | 1-6 weeks | Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regional left ventricular function | 1-6 weeks | regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids. |
| 6 minutes hall walk test | 1-6 weeks | 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 | 1-6 weeks | bloodsamples |
Countries
Denmark
Outcome results
None listed