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

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Medical University of Vienna

Status and phase

Completed
Phase 3
Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: Placebo Oral Capsule
Drug: acipimox

Study type

Interventional

Funder types

Other

Identifiers

NCT01980524
2013-002656-32 (EudraCT Number)
HYPOTESIS

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 64 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

8 participants in 2 patient groups, including a placebo group

acipimox+
Experimental group
Description:
250 mg at 0 and 180 minutes (one day)
Treatment:
Drug: acipimox
Placebo
Placebo Comparator group
Description:
1 Tablet at 0 and 180 minutes (one day)
Treatment:
Drug: Placebo Oral Capsule

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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