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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BYETTA treatment

Drug

Metformine

Drug

Primary outcomes

intracardiac triglyceride

Time frame: 3 years

Cardiac MRI

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Jan 23, 2014
Registry last updated: May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed