Effects of ciprofibrate on myocardial insulin sensitivity in pre-diabetes

Completed

• Conditions: diastolic cardiac failure; impaired cardiac glucose metabolism; 10019280; 10018424

• Registration Number: NL-OMON50730
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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 < 360 ml/kg/min, as
determined using OGIS120

Exclusion Criteria

* Patients with a cardiac disease or with instable angina
* Patients with hepatic or renal failure
* Haemoglobin <7.8 mmol/l
* In case of an abnormal ECG in rest: this will be discussed with the
responsible medical doctor
* HbA1c > 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the difference in myocardial insulin sensitivity<br /><br>(measurement of glucose uptake using radio-active labeled 18F-FDG tracer in<br /><br>PET-MRI) after ciprofibrate administration compared to the placebo trial.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Improves in vivo myocardial mitochondrial function<br /><br>* Lowers intracardiomyocellular lipid content<br /><br>* Improves cardiac diastolic function<br /><br>* Augments hepatic and skeletal muscle glucose uptake<br /><br>* Improves intrahepatic lipid content and composition<br /><br>* Stimulates the PPAR* expression and their down-stream targets in humans<br /><br>(measured in skeletal muscle biopsies)</p><br>