The impact of free fatty acid (FFA-) suppression on myocardial lipids and function in patients with type 2 diabetes
Phase 1
- Conditions
- type 2 diabetesTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2013-002656-32-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ.Klinik für Innere Medizin III, Abt.f.Endokrinologie und Stoffwechsel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
Diagnosis of type 2 diabetes
HbA1C between < 9%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Insulin therapy, except basal insulin adjusted to oral agents
known heart disease incl. coronary artery disease, cardiomyopathy and history of cardiac surgery
known intolerance against niacins
known contraindications against magnetic resonance examinations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Changes in myocardial lipids and function related to suppression of free fatty acids;Secondary Objective: Changes in hepatic lipid content related to suppression of free fatty acids;Primary end point(s): Change in myocardial lipids/ejection fraction after FFA-suppression;Timepoint(s) of evaluation of this end point: after 180 and 240 minutes as well as 24 hours after administration of acipimox
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: after 180 and 240 minutes as well as 24 hours after administration of acipimox;Secondary end point(s): changes in hepatic lipid content