Phase 3 N=8 Randomized Single-blind Basic Science

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

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01980524 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: MYCL — 0.54; 0.44; 0.35; 0.36 percentage of water signal

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: acipimox (Drug); Placebo Oral Capsule (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Medical University of Vienna
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY MYCL	0.54; 0.44; 0.35; 0.36	—
SECONDARY Ejection Fraction	76; 78; 69; 77	—

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01980524). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.