search
Back to results

Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging (LICAS-MR)

Primary Purpose

Type II Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GLP-1 agonists
Cardiac MRI
Follow up by phone
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type II Diabetes

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline Concentration of intramyocardial triglycerides at 6 months
Intramyocardial triglyceride concentration, expressed in %, evaluated by NMR spectroscopy

Secondary Outcome Measures

Full Information

First Posted
March 30, 2018
Last Updated
March 3, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
search

1. Study Identification

Unique Protocol Identification Number
NCT03498001
Brief Title
Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging
Acronym
LICAS-MR
Official Title
Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type II Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GLP-1 agonists
Intervention Description
Liraglutide: 6 mg/ml Semaglutide: 1.34 mg/ml Dulaglutide: de 0.75 mg ou 1.5 mg
Intervention Type
Procedure
Intervention Name(s)
Cardiac MRI
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Follow up by phone
Intervention Description
at 2 and 4 mois
Primary Outcome Measure Information:
Title
Change from Baseline Concentration of intramyocardial triglycerides at 6 months
Description
Intramyocardial triglyceride concentration, expressed in %, evaluated by NMR spectroscopy
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles GUENANCIA
Phone
03.80.29.56.23
Email
charles.guenancia@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs