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

Heart Failure Clinical Trial

— Metamod3  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192373
• Other study ID #: M20090230
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2010
• Last updated: January 18, 2013
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: January 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Heart Failure

Intervention

Other:
• Metabolic substrate modulation
for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
• metabolic substrate modulation
low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.

Locations

Country	Name	City	State
Denmark	Dept. of cardiology, Aarhus University hospital Skejby,	Aarhus	Region Midjylland

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-6 weeks	No
Primary	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.	1-6 weeks	No
Primary	Exercise capacity and oxygen consumption	Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids.	1-6 weeks	No
Secondary	Regional left ventricular function	regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids.	1-6 weeks	No
Secondary	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.	1-6 weeks	No
Secondary	metabolic and hormonal profile	bloodsamples	1-6 weeks	No