Effect of GLP-1 on microvascular function in patients with type 2 diabetes

Phase 1

Conditions: Microvessel angina is a result of myocardial ischemia from insufficient myocardial perfusion secondary to microvessel dysfunction. Diseased arteries may appear angiographically normal but are dysfunctioning and blood flow is not sufficient increased. In the absence of stenosis of major coronary arteries, coronary flow reserve (CFR) reflects coronary microcirculation. CFR is reduced in patients diabetes and is a strong predictor of poor prognosis.
MedDRA version: 14.1Level: LLTClassification code 10065566Term: Microvascular anginaSystem Organ Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2012-005013-38-DK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Age: 40-75 years
Type 2 diabetes with clinical indication of liraglutide treatment (not acceptable glycemic regulation on oral antidiabetic medication)
BMI>25 kg/m2
HbA1c
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Insulin treatment
HbA1c>9 %.
Documented significant stenosis of the left anterior descending artery (LAD) at coronary angiography or CT-angiography.
Pregnancy, physical or mental disability, active cancer, severe co-morbidity with limited life-expectancy, significant renal or hepatic co-morbidity, chronic alcohol abuse or heart failure with a left ventricular ejection fraction

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to explore the short term effects of GLP-1 treatment on coronary microcirculations estimated by coronary flow reserve (CFR) in patients with type 2 diabetes as a pilot study for a long term study;Secondary Objective: Not applicable;Primary end point(s): Coronary flow reserve (CFR). <br><br>;Timepoint(s) of evaluation of this end point: baseline, after 5 weeks and after 10 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Endothelial function. <br>;Timepoint(s) of evaluation of this end point: baseline, after 5 weeks and after 10 weeks of treatment