diastolic cardiac failure impaired cardiac glucose metabolism
Conditions
Interventions
Subjects will be asked to take one pill of ciprofibrate 100mg, or placebo, once
daily (at dinner), for 35 days.
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Sex: male * Age: 40-70 years * BMI: 27-35 kg/m2 * Stable dietary habits: no weight gain or loss > 5kg in the last three months * Insulin resistant: glucose clearance rate below
Exclusion criteria
Exclusion criteria: * Patients with a cardiac disease or with instable angina * Patients with hepatic or renal failure * Haemoglobin 6.5% * Diagnosed with type 1 or type 2 diabetes mellitus * Patients with alcohol abuse * Use of a fibrate * Medication use known to interfere with glucose homeostasis/metabolism * Use of anti-coagulants, excluding platelet aggregation inhibitors * Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed, cannot participate in the study. * Subjects who intend to donate blood during the intervention or subjects who have donated blood less than three months before the start of the intervention. * Participation in another biomedical study within 1 month before the first screening visit * Any condition, disease or abnormal laboratory test result that, in the opinion of the Investigator, would interfere with the study outcome, affect trial participation or put the subject at undue risk * Any contra-indication to MRI scanning. * Participation in earlier research or medical examinations in the past 3 months that included PET/MRI scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is the difference in myocardial insulin sensitivity (measurement of glucose uptake using radio-active labeled 18F-FDG tracer in PET-MRI) after ciprofibrate administration compared to the placebo trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Improves in vivo myocardial mitochondrial function * Lowers intracardiomyocellular lipid content * Improves cardiac diastolic function * Augments hepatic and skeletal muscle glucose uptake * Improves intrahepatic lipid content and composition * Stimulates the PPAR* expression and their down-stream targets in humans (measured in skeletal muscle biopsies) | — |
Countries
Netherlands
Outcome results
None listed