- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03498001
Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging (LICAS-MR)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- CHU Dijon Bourgogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient who has given his consent
- Adult patient over 50 years of age Type II diabetic treated without modification of the antidiabetic treatment during the previous 3 months
- HbA1c ≥ 7%.
- Patient for whom a decision to start a GLP-1 agonist treatment has been made (Liraglutide, Semaglutide, Dulaglutide).
- At least one risk factor from among:
- Treated hypertension,
- treated dyslipidemia,
- History of obesity (BMI>30 kg/m2)
- Active smoking (from 1 cigarette per day) or smoking cessation for less than 3 years,
- Coronary heredity (myocardial infarction or sudden death before age 55 in father/brother, myocardial infarction or sudden death before age 65 in mother/sister)
Exclusion Criteria:
- Protected adult Patient not affiliated to a national health insurance scheme Pregnant or breastfeeding woman Women who intend to become pregnant or of childbearing age and do not use adequate contraceptive methods.
Antidiabetic treatment of the incretin family (DPP4 inhibitor except sitagliptin) Severe renal failure (clearance <30ml/min according to Cockroft due to gadolinium injection) Claustrophobia / contraindication to MRI (compatible non-MRI implanted metallic material) History of hypersensitivity to gadoteric acid or gadolinium-based contrast agents and meglumine Hypersensitivity to Liraglutide, Semaglutide, Dulaglutide or any of the excipients History or presence of pancreatitis (acute or chronic) Chronic inflammatory bowel disease Diabetic gastroparesis Dysthyroidism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients
|
Liraglutide: 6 mg/ml Semaglutide: 1.34 mg/ml Dulaglutide: de 0.75 mg ou 1.5 mg
T3 myocardial MRI (total acquisition time : 1h) performed before initiation of treatment and measuring the concentration of intramyocardial triglycerides ([TG] by NMR spectroscopy, parameters of cardiac morphology (myocardial mass, (epicardial fat surface, pericardial fat surface), function (LVEF, SV, TDV, PFR, TPFR) and tissue parameters (extracellular volume, left myocardial fibrosis volume).
at 2 and 4 mois
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Concentration of intramyocardial triglycerides at 6 months
Time Frame: Month 6
|
Intramyocardial triglyceride concentration, expressed in %, evaluated by NMR spectroscopy
|
Month 6
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GUENANCIA APJ 2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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