Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in coronary flow reserve (CFR)
研究概览
简要总结
The purpose of the study is to determine if a GLP-1 agonist improves microvascular perfusion in the heart of patients with type 2 diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes on monotherapy with metformin or sulfonylurea or combination therapy of metformin and sulfonylurea.
- •Age: 25-75 years
- •BMI>25 kg/m2
- •HbA1c 6,0-10 %
排除标准
- •Current treatment with insulin or Dipeptidyl peptidase IV inhibitor.
- •Haemoglobin < 6.5 mmol/l
- •Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography or regional dysfunction documented during dipyridamol stress-echocardiography. If stress test at baseline shows significant stenosis the patient will be excluded from the study.
- •Allergy towards victoza ® (liraglutide ), Dipyridamol, Nitroglycerin or rescue medicine: Theophyllin
- •Pregnancy
- •Severe asthma
- •Active cancer
- •Severe co-morbidity with limited life-expectancy
- •Estimated glomerular filtration rate (eGFR) <60 (measured at baseline)
- •Severe hepatic co-morbidity
- •Chronic alcohol abuse
- •Heart failure with a left ventricular ejection fraction </= 45%
- •Atrial fibrillation
- •Chronic or previous acute pancreatitis
- •Inflammatory bowel disease.
研究组 & 干预措施
victoza
The study is a cross over study. Patients randomised to start with victoza are treated with victoza for 10 weeks. After a wash out period of 2 weeks they cross over to 10 weeks of no treatment
干预措施: Victoza (Drug)
结局指标
主要结局
Change in coronary flow reserve (CFR)
时间窗: CFR is measured at baseline and after 10 weeks of intervention
CFR can be reliably assessed non-invasively by trans-thoracic Doppler flow echocardiography of the left anterior descending artery with a success rate of over 90% even in an obese population with a relative poor acoustic window. CFR is the ratio of flow during stress to during rest.
次要结局
- Change in Endothelial function:(Endothelial function is measured at baseline and after 10 weeks of intervention)
研究者
Mette Zander
MD, PhD
Bispebjerg Hospital