The Impact of Free Fatty Acid (FFA-) Suppression on Myocardial Lipids and Function in Patients With Type 2 Diabetes
HYPOTESIS
HYPOglycemia Linked to Cardiac sTEatoSIS? - Identifying Mechanisms That Explain Adverse Cardiovascular Outcome Associated With Intensive Glucose Control in Patients With Diabetes (HYPOTESIS)
2 other identifiers
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes
Started Oct 2013
Longer than P75 for phase_2 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 26, 2013
CompletedFirst Posted
Study publicly available on registry
November 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedResults Posted
Study results publicly available
April 4, 2017
CompletedApril 4, 2017
February 1, 2017
2.2 years
October 26, 2013
October 31, 2016
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
MYCL
Intramyocardiocellular lipid content (MYCL) before and after administration of acipimox or placebo
180 minutes
Secondary Outcomes (1)
Ejection Fraction
180 minutes
Other Outcomes (1)
Stroke Volume
180 minutes
Study Arms (2)
acipimox+
EXPERIMENTAL250 mg at 0 and 180 minutes (one day)
Placebo
PLACEBO COMPARATOR1 Tablet at 0 and 180 minutes (one day)
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes
- HbA1C \>6%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Endocrinology and Metabolism, Internal Medicine III, Medical University of Vienna
Vienna, 1090, Austria
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Peter Wolf
- Organization
- Medical University of Vienna
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Krebs, Prof.MD
Medical University of Vienna, Dept. of Internal Medicine III, Division of Endocrinology and Metabolism
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.MD
Study Record Dates
First Submitted
October 26, 2013
First Posted
November 11, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2015
Study Completion
May 1, 2016
Last Updated
April 4, 2017
Results First Posted
April 4, 2017
Record last verified: 2017-02