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Effects of LIraglutide on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging (LICAS-MR)

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ClinicalTrials.gov Identifier: NCT03498001
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Drug: Liraglutide Procedure: Cardiac MRI Other: Follow up by phone Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of LIraglutide on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans
Drug Information available for: Liraglutide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Patients 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



Primary Outcome Measures :
  1. Change from Baseline Concentration of intramyocardial triglycerides at 6 months [ Time Frame: Month 6 ]
    Intramyocardial triglyceride concentration, expressed in µmol/g, evaluated by NMR spectroscopy



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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498001


Locations
France
Chu Dijon Bourgogne Recruiting
Dijon, France, 21000
Contact: Charles GUENANCIA    03.80.29.56.23    charles.guenancia@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03498001     History of Changes
Other Study ID Numbers: GUENANCIA APJ 2016
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists