Effect of GLP-1 on Microvascular Myocardial Function in Patients With Type 2
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Bispebjerg Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in coronary flow reserve (CFR)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 25 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Victoza (Drug)
Outcomes
Primary Outcomes
Change in coronary flow reserve (CFR)
Time Frame: 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 Outcomes
- Change in Endothelial function:(Endothelial function is measured at baseline and after 10 weeks of intervention)
Investigators
Mette Zander
MD, PhD
Bispebjerg Hospital