Current partner codePEPTIDESDE
NCT02042664·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

44

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

BYETTA treatment

DRUG

Metformine

Timeline

From registration to results.

  1. First posted

    Jan 23, 2014

  2. Study start

    Jan 2011

  3. Primary completion

    Jan 2015

  4. Study completion

    Jun 2015

  5. Results posted

    Not reported

  6. Registry updated

    May 7, 2026

Outcomes

What the study measures.

Primary outcomes

intracardiac triglyceride

Time frame · 3 years

Cardiac MRI

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

France. Showing up to 24 locations stored in the fast local snapshot.

Assistance Publique Hopitaux de Marseille

Marseille, France

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

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