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

NCT02042664 | Completed Phase 3

• 2 other identifiers: 2010 -022792-572010-14
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• intracardiac triglyceride

  Cardiac MRI

  3 years

Study Arms (2)

treatment BYETTA

EXPERIMENTAL

Drug: BYETTA treatment

metformine

ACTIVE COMPARATOR

Drug: Metformine

Interventions

BYETTA treatment DRUG

treatment BYETTA

Metformine DRUG

metformine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (2)

• Dutour A, Abdesselam I, Ancel P, Kober F, Mrad G, Darmon P, Ronsin O, Pradel V, Lesavre N, Martin JC, Jacquier A, Lefur Y, Bernard M, Gaborit B. Exenatide decreases liver fat content and epicardial adipose tissue in patients with obesity and type 2 diabetes: a prospective randomized clinical trial using magnetic resonance imaging and spectroscopy. Diabetes Obes Metab. 2016 Sep;18(9):882-91. doi: 10.1111/dom.12680. Epub 2016 May 31.

  PMID: 27106272 RESULT

• Soghomonian A, Dutour A, Kachenoura N, Thuny F, Lasbleiz A, Ancel P, Cristofari R, Jouve E, Simeoni U, Kober F, Bernard M, Gaborit B. Is increased myocardial triglyceride content associated with early changes in left ventricular function? A 1H-MRS and MRI strain study. Front Endocrinol (Lausanne). 2023 Jun 22;14:1181452. doi: 10.3389/fendo.2023.1181452. eCollection 2023.

  PMID: 37424866 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Interventions

Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• LOIC modoloni

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: January 23, 2014
• Study Start: January 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 7, 2026

Record last verified: 2015-08

Locations

FR (1)