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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT02042664 (opens ClinicalTrials.gov in a new tab)Other id2010 -022792-57Other id2010-14
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
44 participants (actual)
Sponsor
Assistance Publique Hopitaux De Marseille · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

France

Start
Jan 2011
Primary completion
Jan 2015
Completion
Jun 2015
First posted
23 Jan 2014 (estimated)
Last update posted
7 May 2026
Conditions
Obesity · Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201120122013201420152016
  1. Ph 3

    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

    Jan 2011 to Jun 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • BYETTA treatmentDrug
  • MetformineDrug

Arms2

  • Experimental

    treatment BYETTA

  • Active comparator

    metformine

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. intracardiac triglyceride

    Time frame · 3 years

    Registry description

    Cardiac MRI

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2016

8 results

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.

Dutour et al. 2016Diabetes, obesity & metabolismcited by 213

PMID 27106272DOI 10.1111/dom.12680PUB-27106272

Full text at the publisher8 results
Publisher pageSee results (8)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSoghomonian 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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