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
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.
研究概览
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Marseille、法国、13354
- Assistance Publique Hopitaux de Marseille
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:treatment BYETTA
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有源比较器:metformine
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
intracardiac triglyceride
大体时间:3 years
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Cardiac MRI
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3 years
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合作者和调查者
调查人员
- 研究主任:LOIC modoloni、Assistance Publique Hopitaux de Marseille
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
BYETTA treatment的临床试验
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Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus招聘中
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Universitaire Ziekenhuizen KU LeuvenLaboratoires Thea招聘中
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AstraZenecaEli Lilly and Company完全的
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University Hospital, CaenEli Lilly and Company未知
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University of Colorado, DenverNational Center for Advancing Translational Sciences (NCATS)完全的