Effect of Glucagon-like Peptide 1 (GLP-1) on Microvascular Myocardial Function in Patients With Type 2 Diabetes.

Study Overview
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Brief Summary
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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

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

Conditions
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Type 2 Diabetes, Microvascular Dysfunction

Intervention / Treatment
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* Drug: Victoza


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: victoza<br>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 | Drug: Victoza<br> <br> |
| No Intervention: No treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coronary flow reserve (CFR) | 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. | CFR is measured at baseline and after 10 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Endothelial function: | 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). | Endothelial function is measured at baseline and after 10 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, GLP-1, Victoza, CFR, microvascular dysfunction