Ciprofibrate and pre-diabetes

Phase 1

• Conditions: Insulin resistance, diastolic cardiac failure, mitochondrial function; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2018-001663-22-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-16
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12

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
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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Patients with a cardiac disease or with instable angina
•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
•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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine whether ciprofibrate treatment can improve myocardial insulin sensitivity in subjects with IGM (impaired glucose metabolism).;Secondary Objective: To examine whether ciprofibrate treatment in IGM:<br>•Improves in vivo myocardial mitochondrial function<br>•Lowers intracardiomyocellular lipid content<br>•Improves cardiac diastolic function<br>•Augments hepatic and skeletal muscle glucose uptake<br>•Improves intrahepatic lipid content and composition<br>•Stimulates the PPARa expression and their down-stream targets in humans (measured in skeletal muscle biopsies);Primary end point(s): Myocardial glucose uptake;Timepoint(s) of evaluation of this end point: After 35 days supplementation ciprofibrate

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Insulin sensitivity in clamp procedure;Timepoint(s) of evaluation of this end point: After 35 days supplementation ciprofibrate