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
概览
- 阶段
- 3 期
- 干预措施
- Metformine
- 疾病 / 适应症
- Obesity
- 发起方
- Assistance Publique Hopitaux De Marseille
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- intracardiac triglyceride
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
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.
研究者
入排标准
入选标准
- •- 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
排除标准
- •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.
研究组 & 干预措施
metformine
干预措施: Metformine
treatment BYETTA
干预措施: BYETTA treatment
结局指标
主要结局
intracardiac triglyceride
时间窗: 3 years
Cardiac MRI