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Completed

NCT Number: NCT01980524

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acipimox

Drug

Placebo oral capsule

Drug

Primary outcomes

  1. MYCL

    Time frame: 180 minutes

    Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo

Secondary outcomes

  1. Ejection Fraction

    Time frame: 180 minutes

    Left ventricular ejection fraction before and after administration of acipimox or placebo

Other outcomes

  1. Stroke Volume

    Time frame: 180 minutes

    Stroke volume before and after administration of acipimox or placebo

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

HYPOglycemia Linked to Cardiac sTEatoSIS? - Identifying Mechanisms That Explain Adverse Cardiovascular Outcome Associated With Intensive Glucose Control in Patients With Diabetes (HYPOTESIS)

Acronym: HYPOTESIS

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Nov 11, 2013
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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