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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02042664
• Other study ID #: 2010 -022792-57
• Secondary ID: 2010-14
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2013
• Last updated: August 28, 2015
• Start date: January 2011
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Drug:
• BYETTA treatment

• Metformine

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracardiac triglyceride	Cardiac MRI	3 years	No