The Effect of GLP-1 Receptor Agonist on Cerebral Blood Flow Velocity in Non-stroke Volunteers

NCT02838589 | Completed Phase 2 DMC

• 2 other identifiers: H-160225322016-001221-14
• 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 on cerebral blood flow velocity and cortical oxygination in humans without cerebrovascular disease. This study serves as a control for a similar study investigating the effect in stroke patients (ref. to EGRABIS1).

Conditions

Stroke

Keywords

Cerebrovascular Stroke; Ischemic Stroke; 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)

• Changes in the endothelial reactivity measured by non-invasive pletysmography.

  3 hours

• Changes in the endothelial/inflammatory biomarkers in blood.

  3 hours

• Changes in the 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) 3. Endothelial function/response by the methods: * Biomarkers in blood (eg. e-selectin, VCAM, ICAM, endothelin, ADMA, miRNA) * EndoPAT2000 * Ankle-brachial index

Drug: Byetta

Isotonic saline

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) 3. Endothelial function/response by the methods: * Biomarkers in blood (eg. e-selectin, VCAM, ICAM, endothelin, ADMA, miRNA) * EndoPAT2000 * Ankle-brachial index

Drug: Isotonic saline

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

Isotonic saline DRUG

Single dose of subcutaneous injection of 20 μL isotonic saline (placebo).

Also known as: Normal saline

Isotonic saline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person ≥ 50 years of age
• Has given written informed consent

You may not qualify if:

• Intracerebral haemorrhage
• Subdural / epidural hemorrhage
• subarachnoid haemorrhage
• previously major structural damage to the brain (eg. sequelae after large stroke or brain surgery)
• 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

Location

Related Publications (1)

• Olmestig J, Marlet IR, Vilsboll T, Rungby J, Rostrup E, Lambertsen KL, Kruuse C. A single dose of exenatide had no effect on blood flow velocity in the middle cerebral artery in elderly healthy volunteers: Randomized, placebo-controlled, double-blind clinical trial. Front Aging Neurosci. 2022 Jul 25;14:899389. doi: 10.3389/fnagi.2022.899389. eCollection 2022.

  PMID: 36636739 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Exenatide; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; 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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Christina R Kruuse, MD, PhD

  Consultant Neurologist, Dept Neurology, Herlev Hospital

  PRINCIPAL INVESTIGATOR

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 20, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 7, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)