Overview

Effects of LIraglutide on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging

Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Treatments:
Liraglutide
Criteria
Inclusion Criteria:

- Patient who has given consent

- Adult patient over the age of 50 for men and over 60 for women

- Type II diabetes treated without modification of antidiabetic treatment in the
previous 3 months

- HbA1c ≥ 7.5%

- At least one of:

- treated high blood pressure,

- obesity (BMI>30 kg/m2),

- treated dyslipidemia,

- Active smoking (from 1 cigarette per day) or quit less than 3 years ago,

- hereditary coronary heart disease (myocardial infarction or sudden death before the
age of 55 in the father/brother, myocardial infarction or sudden death before the age
of 65 in the mother/sister)

- patient for whom a decision to start add-on treatment with Liraglutide has been made.

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 (GLP-1 agonist or DPP4 inhibitor) 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 VICTOZA® or any of the excipients History or presence of
pancreatitis (acute or chronic) Chronic inflammatory bowel disease Diabetic gastroparesis
Dysthyroidism