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
NCT ID: NCT02042664
Last Updated: 2015-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
44 participants
INTERVENTIONAL
2011-01-31
2015-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment BYETTA
BYETTA treatment
metformine
Metformine
Interventions
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BYETTA treatment
Metformine
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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LOIC modoloni
Role: STUDY_DIRECTOR
Assistance Publique Hopitaux De Marseille
Locations
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Assistance Publique Hopitaux de Marseille
Marseille, , France
Countries
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References
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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.
Other Identifiers
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2010-14
Identifier Type: OTHER
Identifier Source: secondary_id
2010 -022792-57
Identifier Type: -
Identifier Source: org_study_id