The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo Oral Capsule; Drug: acipimox

• Registration Number: NCT01980524
• Lead Sponsor: Medical University of Vienna

Brief Summary

There is evidence that inhibition of FFA-release by acipimox is associated with a significant decrease in myocardial lipid content (MYCL) as well as the ejection fraction (as a marker of systolic left ventricular function) in healthy subjects, indicating, that the heart is dependent on a constant supply of free fatty acids in order to guarantee normal cardiac function, and it further indicates, that the heart is not able to cover its energy demand by switching to glucose oxidation.

Since that phenomenon, better known as "metabolic inflexibility" has been mainly described in patients with diabetes, we aim to investigate the impact of FFA-inhibition on MYCL and cardiac function in patients with overt type 2 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-11
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Results First Submitted: 2016-10-31
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-16
• Last Update Submitted: 2017-02-16
• Results First Posted: 2017-04-04
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Type 2 Diabetes
• HbA1C >6%

Exclusion Criteria

• Insulin therapy (except: BOT=basal supported oral therapy)
• Known heart disease including coronary artery disease, cardiomyopathy, history of cardiac surgery
• Known intolerance against niacins
• Known contra-indications against magnetic resonance (MR-) examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Capsule	1 Tablet at 0 and 180 minutes (one day)
acipimox+	acipimox	250 mg at 0 and 180 minutes (one day)

Primary Outcome Measures

Name	Time	Method
MYCL	180 minutes	Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo

Secondary Outcome Measures

Name	Time	Method
Ejection Fraction	180 minutes	Left ventricular ejection fraction before and after administration of acipimox or placebo

Trial Locations

Locations (1)

Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna; 🇦🇹 Vienna, Austria