Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: "Effect on Left Ventricular Function" (Metamod3)

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Diabetes; Heart Failure

Treatments: Other: Metabolic substrate modulation; Other: metabolic substrate modulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01192373

M20090230

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups

High circulating free fatty acids

Experimental group

Description:

using Heparin af intralipid infusion for 8 hours

Treatment:

Other: Metabolic substrate modulation

Low circulation free fatty acids

Active Comparator group

Description:

using hyperinsulinaemic euglycemic clamp for 8 hours

Treatment:

Other: metabolic substrate modulation