Effect of intact GLP-1 (7-36) and GLP-1 metabolite (9-36) on coronary and peripheral vascular function in adults

Effect of intact GLP-1 (7-36) and GLP-1 metabolite (9-36) on coronary and peripheral vascular function in adults - EIMA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001240-64-DK

Enrollment

Registered

2013-07-09

Start date

2013-07-09

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular myocardial dysfunction MedDRA version: 19.1 Level: HLT Classification code 10012654 Term: Diabetic complications cardiovascular System Organ Class: 100000004860

Interventions

Trade Name: Januvia Product Name: januvia Product Code: EMEA/H/C/000722 Pharmaceutical Form: Tablet INN or Proposed INN: Januvia Other descriptive name: SITAGLIPTIN Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 Hypothesis 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. ;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	—

Measure

Time frame

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 Hypothesis 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. ;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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactMette Zander

Bispebjerg Hospital

m.zander@dadlnet.dk004551543686

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026