Microvascular Dysfunction, Type 2 Diabetes
Conditions
Keywords
diabetes, GLP-1, Victoza, CFR, microvascular dysfunction
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
Interventions
DRUGVictoza
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame |
|---|---|
| Change in fasting insulin | Fasting insulin is measured at baseline and after 10 weeks of intervention |
| Change in fasting glucose | Fasting glucose is measured at baseline and after 10 weeks of intervention |
| Changes in HbA1c | Measurements at baseline and after 10 weeks of intervention |
| Change in waist circumference | Waist circumference is measured at baseline and after 10 weeks of intervention |
| Change in weight | Weight is measured at baseline and after 10 weeks of intervention |
| Change in fasting C-peptide | C-peptide is measured at baseline and after 10 weeks of intervention |
Countries
Denmark
Outcome results
None listed