DRUG
Effect of GLP-1 Receptor (GLP-1R) Agonists on Cardiac Function and on Epicardial Adipose Tissue (EAT) Volume and on Myocardial TG Content in Obese Diabetics
Status
Completed
Phase
Phase 3
Enrollment
44
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
Glucagon-like peptide-1 (GLP-1) receptor agonist are new treatment of type 2 diabetes, they lower blood glucose level (by enhancement of glucose-dependent insulin secretion and suppression of excess glucagon secretion) and reduce weight by inducing satiety and slowing of gastric emptying. Beneficial effects of GLP-1 and GLP-1 receptor (GLP-1R) agonists on cardiovascular function have been suggested. They improve biomarkers of CV risk, decrease systolic blood pressure, improve endothelial function and have beneficial effects on myocardium. Nevertheless, few studies have analysed the effect of GLP1 treatment on myocardial function in type 2 obese diabetic. Myocardial steatosis is an independent predictor of diastolic dysfunction in type 2 diabetes mellitus. It was recently shown that 16 weeks of caloric restriction in obese patients with diabetes decrease myocardial triglyceride content and improve myocardial function (cardiac output, normalized stroke volume, LV mass and normalized end diastolic volume), and diastolic function. However, no study has evaluated the impact of Glucagon-like peptide-1 (GLP-1) receptor agonist in obese diabetics on myocardial TG content. Recent studies have suggested that increased epicardial adipose tissue (EAT) could be an important risk factor for cardiac diseases. We and others have already evidenced a correlation between the volume of epicardial adipose tissue and the presence or the severity of coronaropathy. The impact of weight loss on the volume of EAT or the characteristics of EAT is mostly unknown.
Interventions
Treatment arms and agents.
DRUG
Metformine
Timeline
From registration to results.
First posted
Jan 23, 2014
Study start
Jan 2011
Primary completion
Jan 2015
Study completion
Jun 2015
Results posted
Not reported
Registry updated
May 7, 2026
Outcomes
What the study measures.
Primary outcomes
intracardiac triglyceride
Time frame · 3 years
Cardiac MRI
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * \- Patients with type 2 diabetes according to WHO criteria * Age\> 18 years * BMI ≥ 30 kg/m2 * HbA1c\> 7% and \<10% * Processing by ADO (Metformin and Glimepiride) * Effective contraception (for women) * Signed informed consent by the patient before inclusion in the protocol Exclusion Criteria: * Ongoing pregnancy or become pregnant within six months of the study protocol * Breastfeeding * Recent weight loss (\> 5% of total weight) * Treatments changing the distribution of adipose tissue as corticosteroids or glitazones * Acute coronary syndrome or unstable angina during the last three months * Contraindications to cardiac MRI (mechanical heart valve, pacemaker, metallic intraocular foreign body, claustrophobia) * Contraindication to cold test: Raynaud's syndrome * Contraindication to exenatide: * Neoplasia active or untreated or in remission for less than 5 years (except for basal cell carcinoma or in situ cervical or prostate) * Contraindication to ADO (depending on specific product) in combination with exenatide. * History of kidney transplant or dialysis or plasmatique creatinine\> 1.5 mg / dL for men and\> 1.2 mg / dL for women * Digestive diseases, including gastroparesis * plasma triglycerides\> 1000 mg / dL * History of pancreatitis confirmed biologically * contraindication or hypersensitivity to Exenatide or one of its social coverage composantsAbsence
Study locations
1 registered sites.
France. Showing up to 24 locations stored in the fast local snapshot.
Assistance Publique Hopitaux de Marseille
Marseille, France
Publications
Results and literature.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.