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

Phase 4CompletedNCT01931982

Bispebjerg Hospital20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Microvascular Dysfunction

Interventions

VictozaDRUG

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bispebjerg Hospital

Copenhagen, Capital Region, Denmark

Outcomes

Primary Outcomes

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.

Time frame: CFR is measured at baseline and after 10 weeks of intervention

Secondary Outcomes

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).

Time frame: Endothelial function is measured at baseline and after 10 weeks of intervention

Data from ClinicalTrials.gov

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