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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03498001
Other study ID # GUENANCIA APJ 2016
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 16, 2018
Est. completion date December 2020

Study information

Verified date April 2018
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
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 Recruiting
Enrollment 42
Est. completion date December 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Liraglutide
6 mg/ml
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 ┬Ámol/g, evaluated by NMR spectroscopy Month 6
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