Current partner codePEPTIDESDE
NCT03498001·Not applicable·INTERVENTIONAL

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

Status

Completed

Phase

Not applicable

Enrollment

42

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Apr 13, 2018

  2. Study start

    Apr 16, 2018

  3. Primary completion

    Jun 6, 2023

  4. Study completion

    Dec 20, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Feb 4, 2026

Outcomes

What the study measures.

Primary outcomes

Change from Baseline Concentration of intramyocardial triglycerides at 6 months

Time frame · Month 6

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Chu Dijon Bourgogne

Dijon, France

Related trials

More studies on Liraglutide.

Related PeptideStat pages

Put the record in context.

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