- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01192373
Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function" (Metamod3)
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"
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Region Midjylland
-
Aarhus, Region Midjylland, Denmark, 8200
- Dept. of cardiology, Aarhus University hospital Skejby,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High circulating free fatty acids
using Heparin af intralipid infusion for 8 hours
|
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
|
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
1-6 weeks
|
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. |
1-6 weeks
|
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.
|
1-6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1-6 weeks
|
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.
|
1-6 weeks
|
metabolic and hormonal profile
Time Frame: 1-6 weeks
|
bloodsamples
|
1-6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Roni R Nielsen, MD, Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M20090230
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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