Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging

Type II Diabetes Clinical Trial

— LICAS-MR  

Official title:

Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498001
• Other study ID #: GUENANCIA APJ 2016
• Status: Completed
• Phase: N/A
• Start date: April 16, 2018
• Est. completion date: December 20, 2023

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Type II diabetes is a known risk factor for heart failure, particularly through the progressive development of diabetic cardiomyopathy. Cardiac metabolic parameters, including myocardial steatosis and epicardial fat, are altered in diabetic patients. The development of new anti-diabetics (incretins) has demonstrated protective cardiovascular effects independent of effects on glycemic control for the first time in the history of these therapies. Thus Glucagon-Like Peptide 1 (GLP-1) agonists improve the recovery of cardiac function after a heart attack and decrease atheromatous processes. It has also been demonstrated in a diabetic rat model that the administration of Liraglutide, a GLP-1 agonist, leads to normalization of myocardial steatosis associated with beneficial cardiac molecular remodeling involving pro-apoptotic, oxidative and metabolic processes. These beneficial cardiovascular effects were observed in the absence of any changes in blood glucose, insulin levels or body weight.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 20, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Drug:
• GLP-1 agonists
Liraglutide: 6 mg/ml Semaglutide: 1.34 mg/ml Dulaglutide: de 0.75 mg ou 1.5 mg

Procedure:
• Cardiac MRI
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).

Other:
• Follow up by phone
at 2 and 4 mois

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Concentration of intramyocardial triglycerides at 6 months	Intramyocardial triglyceride concentration, expressed in %, evaluated by NMR spectroscopy	Month 6