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

NCT03498001 | Completed

• 1 other identifier: GUENANCIA APJ 2016
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Concentration of intramyocardial triglycerides at 6 months

  Intramyocardial triglyceride concentration, expressed in %, evaluated by NMR spectroscopy

  Month 6

Study Arms (1)

Patients

EXPERIMENTAL

Drug: GLP-1 agonists; Procedure: Cardiac MRI; Other: Follow up by phone

Interventions

GLP-1 agonists DRUG

Liraglutide: 6 mg/ml Semaglutide: 1.34 mg/ml Dulaglutide: de 0.75 mg ou 1.5 mg

Patients

Cardiac MRI PROCEDURE

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).

Patients

Follow up by phone OTHER

at 2 and 4 mois

Patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

• Houbachi L, Walker PM, Fournel I, Ksiazek E, Petit JM, Cochet A, Leclercq T, Roger A, Simoneau I, Bouillet B, Guenancia C. Evolution of myocardial steatosis in high cardiovascular risk T2DM patients treated by GLP1 receptor agonists: LICAS study. Diabetes Res Clin Pract. 2025 Mar;221:112017. doi: 10.1016/j.diabres.2025.112017. Epub 2025 Feb 1.

  PMID: 39900263 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Glucagon-Like Peptide-1 Receptor Agonists

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hypoglycemic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2018
• First Posted: April 13, 2018
• Study Start: April 16, 2018
• Primary Completion: June 6, 2023
• Study Completion: December 20, 2023
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)