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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT02042664
First received: September 11, 2013
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Obesity
Diabetes
Drug: BYETTA treatment
Drug: Metformine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • intracardiac triglyceride [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Cardiac MRI


Estimated Enrollment: 44
Study Start Date: January 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment BYETTA Drug: BYETTA treatment
Active Comparator: metformine Drug: Metformine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042664

Contacts
Contact: benedicte gaborit benedicte.gaborit@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: benedicte gaborit       benedicte.gaborit@ap-hm.fr   
Principal Investigator: benedicte gaborit         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC modoloni Assistance Publique Hopitaux De Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02042664     History of Changes
Other Study ID Numbers: 2010 -022792-57, 2010-14
Study First Received: September 11, 2013
Last Updated: August 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 23, 2014