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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

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ClinicalTrials.gov Identifier: NCT02042664
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Obesity Diabetes Drug: BYETTA treatment Drug: Metformine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: treatment BYETTA Drug: BYETTA treatment
Active Comparator: metformine Drug: Metformine



Primary Outcome Measures :
  1. intracardiac triglyceride [ Time Frame: 3 years ]
    Cardiac MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042664


Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: LOIC modoloni Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02042664     History of Changes
Other Study ID Numbers: 2010 -022792-57
2010-14 ( Other Identifier: AP HM )
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: August 31, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Exenatide
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists