Effect of intact GLP-1 (7-36) and GLP-1 metabolite (9-36) on coronary and peripheral vascular function in adults
Phase 1
- Conditions
- MedDRA version: 19.1Level: HLTClassification code 10012654Term: Diabetic complications cardiovascularSystem Organ Class: 100000004860Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Microvascular myocardial dysfunction
- Registration Number
- EUCTR2013-001240-64-DK
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
Age 35-70 years
BMI > 25 kg/m2.
Central obesity
Non smoker
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 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
Known Diabetes
Known hypertension
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.
Pregnancy
Severe astma
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 the study is to explore the acute mechanistic effects of intact and metabolized GLP-1 on CFR and endothelial function in obese patients<br><br>Hypothesis<br>The effect of GLP-1 on CFR is dependent on both GLP-1(7-36) and metabolised GLP-1(9-36) and the effect is both receptor mediated and receptor independent. Thus GLP-1 (7-36) and GLP-1 (9-36) improve CFR and endothelial function in adults compared to saline. <br>;Secondary Objective: Not applicable;Primary end point(s): Changes in CFR during GLP-1 (9-36), GLP-1 (7-36) + DPP-IV inhibitor and saline infusion assed by a non-invasive trans-thoracic Doppler flow echocardiography.;Timepoint(s) of evaluation of this end point: Before infusion and after 2 hours of infusion
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Changes in endothelial function during GLP-1 (9-36), GLP-1 (7-36) + DPP-IV inhibitor and saline infusion assed by flow mediated dilation (FMD). ;Timepoint(s) of evaluation of this end point: before and after 1 hour of infusion