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

NCT02829502 | Unknown Phase 2 DMC

• 2 other identifiers: H-160225382016-001219-18
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Keywords

Cerebrovascular disease; Glucagon like peptide 1

Outcome Measures

Primary Outcomes (1)

• Changes in the mean flow velocity in the middle cerebral arteries and in cortical oxigination.

  Change in the mean flow velocity in the middle cerebral arteries will be measured with transcranial doppler and cortical oxygination by near infrared spectroscopy (NIRS) before and up till tree hours after injection of exenatide/placebo.

  Up till 3 hours

Secondary Outcomes (3)

• Endothelial reactivity

  3 hours

• Changes in endothelial biomarkers in blood

  3 hours

• Endothelial function/response in ankle-brachial index

  3 hours

Study Arms (2)

Byetta

ACTIVE COMPARATOR

Pre- and post treatment investigations: 1. Mean flow velocity of the middle cerebral arteries bilateral by transcranial doppler 2. Cerebral cortical oxygination by near infrared spectroscopy (NIRS) Endothelial function/response by the methods: * Biomarkers in blood (eg. e-selectin, VCAM, ICAM, endothelin, ADMA, miRNA) * EndoPAT2000 * Ankle-brachial index

Drug: Byetta

Normosaline

PLACEBO COMPARATOR

Pre- and post treatment investigations: 1. Mean flow velocity of the middle cerebral arteries bilateral by transcranial doppler 2. Cerebral cortical oxygination by near infrared spectroscopy (NIRS) Endothelial function/response by the methods: * Biomarkers in blood (eg. e-selectin, VCAM, ICAM, endothelin, ADMA, miRNA) * EndoPAT2000 * Ankle-brachial index

Drug: Normosaline

Interventions

Byetta DRUG

Single dose of subcutaneous injection of 5 μg exenatide (Byetta).

Also known as: Exenatide, GLP-1 receptor analogue, GLP-1 receptor agonist

Byetta

Normosaline DRUG

Single dose of subcutaneous injection of 20 μL normosaline (placebo).

Also known as: Isotonic saline

Normosaline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christina Kruuse: lead

Study Sites (1)

Department of Neurology, Herlev-Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Cerebrovascular Disorders

Interventions

Exenatide; Sodium Chloride

Condition Hierarchy (Ancestors)

Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christina R Kruuse, MD,PhD

  Study Principal Investigator, Consultant Neurologist, Dept. Neurology, Herlev Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina R Kruuse, MD, PhD

CONTACT

+4538681233; ckruuse@dadlnet.dk

Bilal H Akram, med. student

CONTACT

+38681138; bilal.hussain.akram.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, DMSc, consultant Neurologist, Associate Professor

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 12, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)