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临床试验/NCT01931982
NCT01931982已完成4 期

Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Zander

MD, PhD

Bispebjerg Hospital

研究点 (1)

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