The Effect of GLP-1 Receptor Agonist on Cerebral Blood Flow Velocity in Stroke

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized controlled trial investigates the effect of a single dose of glucagon-like peptide-1 (GLP-1) receptor agonist in the subacute phase of stroke in humans. The primary endpoint is the mean flow velocity in the middle cerebral arteries measured by transcranial doppler and cortical oxygination measured by near infrared spectroscopy (NIRS). The secondary endpoints are changes in endothelial/inflammatory biomarkers in the blood, changes in the ankle-brachial index and changes in the reactive hyperaemia index measured by EndoPAT2000.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Christina Kruuse
• Treatments: Exenatide; Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria:

• Patients ≥ 18 years with newly symptoms of stroke

• Able to receive exenatide/placebo within 21 days after onset of symptoms

• Radiological confirmed diagnoses of ischemic stroke

• NIHSS between 1-20 at the onset of symptoms

• modified rankin scale (mRS) ≤ 2 prior to onset of symptoms

• Has given written informed consent

Exclusion Criteria:

• Intracerebral haemorrhage

• Subdural / epidural hemorrhage

• Subarachnoid haemorrhage

• Previously major structural damage to the brain

• Diabetes type 1

• Diabetes type 2

• Known atrial fibrillation

• > 50% stenosis of internal carotid

• Known allergy to GLP-1 receptor agonists

• 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 unable to co-operate to the investigation procedures

• Visualization of the middle cerebral artery bilaterally by transcranial dopple not possible