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临床试验/NCT03498001
NCT03498001
已完成
不适用

Effects of GLP-1 Agonists on CArdiac Steatosis Evaluated by Magnetic Resonance Imaging

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 42 人2018年4月16日

概览

阶段
不适用
干预措施
GLP-1 agonists
疾病 / 适应症
Type II Diabetes
发起方
Centre Hospitalier Universitaire Dijon
入组人数
42
试验地点
1
主要终点
Change from Baseline Concentration of intramyocardial triglycerides at 6 months
状态
已完成
最后更新
2个月前

概览

简要总结

Type II diabetes is a known risk factor for heart failure, particularly through the progressive development of diabetic cardiomyopathy. Cardiac metabolic parameters, including myocardial steatosis and epicardial fat, are altered in diabetic patients. The development of new anti-diabetics (incretins) has demonstrated protective cardiovascular effects independent of effects on glycemic control for the first time in the history of these therapies. Thus Glucagon-Like Peptide 1 (GLP-1) agonists improve the recovery of cardiac function after a heart attack and decrease atheromatous processes. It has also been demonstrated in a diabetic rat model that the administration of Liraglutide, a GLP-1 agonist, leads to normalization of myocardial steatosis associated with beneficial cardiac molecular remodeling involving pro-apoptotic, oxidative and metabolic processes. These beneficial cardiovascular effects were observed in the absence of any changes in blood glucose, insulin levels or body weight.

注册库
clinicaltrials.gov
开始日期
2018年4月16日
结束日期
2023年12月20日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Patient who has given his consent
  • Adult patient over 50 years of age Type II diabetic treated without modification of the antidiabetic treatment during the previous 3 months
  • HbA1c ≥ 7%.
  • Patient for whom a decision to start a GLP-1 agonist treatment has been made (Liraglutide, Semaglutide, Dulaglutide).
  • At least one risk factor from among:
  • Treated hypertension,
  • treated dyslipidemia,
  • History of obesity (BMI\>30 kg/m2)
  • Active smoking (from 1 cigarette per day) or smoking cessation for less than 3 years,
  • Coronary heredity (myocardial infarction or sudden death before age 55 in father/brother, myocardial infarction or sudden death before age 65 in mother/sister)

排除标准

  • \- Protected adult Patient not affiliated to a national health insurance scheme Pregnant or breastfeeding woman Women who intend to become pregnant or of childbearing age and do not use adequate contraceptive methods.
  • Antidiabetic treatment of the incretin family (DPP4 inhibitor except sitagliptin) Severe renal failure (clearance \<30ml/min according to Cockroft due to gadolinium injection) Claustrophobia / contraindication to MRI (compatible non-MRI implanted metallic material) History of hypersensitivity to gadoteric acid or gadolinium-based contrast agents and meglumine Hypersensitivity to Liraglutide, Semaglutide, Dulaglutide or any of the excipients History or presence of pancreatitis (acute or chronic) Chronic inflammatory bowel disease Diabetic gastroparesis Dysthyroidism

研究组 & 干预措施

Patients

干预措施: GLP-1 agonists

Patients

干预措施: Cardiac MRI

Patients

干预措施: Follow up by phone

结局指标

主要结局

Change from Baseline Concentration of intramyocardial triglycerides at 6 months

时间窗: Month 6

Intramyocardial triglyceride concentration, expressed in %, evaluated by NMR spectroscopy

研究点 (1)

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