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

Type 2 Diabetes Clinical Trial

— HYPOTESIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980524
• Other study ID #: HYPOTESIS
• Secondary ID: 2013-002656-32
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 26, 2013
• Last updated: May 4, 2016
• Start date: October 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• acipimox

Locations

Country	Name	City	State
Austria	Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	stroke volume		2 hours	No
Primary	MYCL		2 hours	No
Secondary	Ejection fraction		2 hours	No