GLP-1 and stroke

Phase 1

• Conditions: Stroke; MedDRA version: 19.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-001219-18-DK
• Lead Sponsor: Herlev Gentofte Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-22
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients = 18 years with new-onset symptoms of stroke
• Must be able to receive GLP-1 RA / placebo medication within 21 days after the onset of symptoms
• Radiological verified diagnosis of stroke
• NIHSS between 1-20 at the onset of symptoms
• mRS = 2 prior to onset of symptoms
• Has given written informed consent

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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

• Intracerebral haemorrhage
• Subdural / epidural hemorrhage
• subarachnoid haemorrhage
• previously major structural damage to the brain (eg. sequelae after large stroke or brain surgery)
• Type 1 diabetes
• Type 2 diabetes
• Known atrial fibrillation
• > 50% stenosis of halskar
• Known allergy to GLP-1 RA preparations
• Hepatic impairment (ALT> 3 x upper normal limit)
• Renal impairment (eGFR <30 ml / min)
• Inflammatory bowel disease
• Previous pancreatitis
• Heart failure (NYHA class 3-4)
• Pregnancy or lactation
• Patient is not expected to co-operate to the investigations
• Visualization of the middle cerebral artery bilaterally by transcranial doppler not possible

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to investigate the effect of a single dose of 5 mikrogram GLP-1 receptor agonist ( exenatid ) on blood flow velocity and cortical oxigination in patients with iscaemic stroke. ;Secondary Objective: Secondary objectives of this study is to investigate if the GLP-1 receptor agonist ( exenatid ) improves the peripheral endothelial function measured as an improved blood vessel respons in the fingers after a short occlusion of blood suply to the arm measured with endoPAT2000 and by measuring the blood pressure in the ancles (ancle-brachial index). Besides of that is the objective to examine the endothelial function, and inflammation through specific biomarkers.;Primary end point(s): Primary endpoint is changes in the mean blood flow velocity (Vmean) in the middle cerebral artery and in the cortical oxigination.;Timepoint(s) of evaluation of this end point: Up to three hours after injection of exenatid.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Changes in peripheral vascular function measured by EndoPAT and changes in the ancle-brachial index<br>- Changes in inflammatory- and endothelial function markers in the blood.;Timepoint(s) of evaluation of this end point: Up to three hours after injection of exenatid.