Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.
- Registration Number
- NCT01931982
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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 %
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description victoza 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
- Primary Outcome Measures
Name Time Method Change in coronary flow reserve (CFR) 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.
- Secondary Outcome Measures
Name Time Method Change in Endothelial function: Endothelial function is measured at baseline and after 10 weeks of intervention Measurement of Peripheral Arterial Tone, with the use of the commercially available machine (Endo-PAT2000®) assesses the control of digital vascular tone by the sympathetic nervous system and nitric oxide (NO).
Trial Locations
- Locations (1)
Bispebjerg Hospital
🇩🇰Copenhagen, Capital region, Denmark