Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans

Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients

Studying glucagon-like peptide-1 (GLP-1) induced vasodilatory effects on extra - and intracerebral arteries and headache in healthy volunteers and migraine patients without aura.

Study Overview

• Status: Unknown
• Conditions: Headache, Migraine
• Intervention / Treatment: Other: GLP-1 peptide; Other: Placebo

Detailed Description

The purpose of this study is to examine the association between vasodilation and intensity of headache triggered by glucagon-like peptide 1 (GLP-1) in healthy volunteers and migraine patients without aura.

• Study Type: Interventional
• Enrollment (Anticipated): 43
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hashmat Ghanizada, MD; Phone Number: 38633470; Email: hashmat.ghanizada@regionh.dk

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Recruiting
    • Dansk Hovedpinecenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Criteria for the healthy volunteers group

Inclusion Criteria:

• Healthy men/women.
• Age 18 to 60 years old.
• Weight 50 to 100 kg.

Exclusion Criteria:

• Tension headache more than 5 days a month in the preceding year.
• All other primary headache types.
• Headache on the examination day or within 48 hours before infusion of the study drug.
• Smoking.
• Daily intake of medicine of any kind except for peroral contraceptives.
• Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
• Hypertension or hypotension.
• Coronary heart disease of any kind, as well as cerebrovascular disease.
• Pulmonary disease.
• Allergy to contents in the study drug.
• Psychiatric disease or substance abuse.
• Disease of any kind which the examining doctor deems relevant for participation in the study.
• Renouncing the right to information concerning own health.

Criteria for the migraine patients group

Inclusion Criteria:

• Migraine patients, who fulfill the ICHD-3 criteria for migraine without aura.
• Age 18 to 60 years old.
• Weight 50 to 100 kg.

Exclusion Criteria:

• Tension headache more than 5 days a month in the preceding year.
• All other primary headache types.
• Headache on the examination day or within 48 hours before infusion of the study drug.
• Smoking.
• Daily intake of medicine of any kind except for peroral contraceptives.
• Women, who on the day of examination is 2 days before or 3 days from the first day of bleeding.
• Hypertension or hypotension.
• Coronary heart disease of any kind, as well as cerebrovascular disease.
• Pulmonary disease.
• Allergy to contents in the study drug.
• Psychiatric disease or substance abuse.
• Disease of any kind which the examining doctor deems relevant for participation in the study.
• Renouncing the right to information concerning own health.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GLP-1; Receive intravenous infusion of GLP-1.	Other: GLP-1 peptide; Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.
Placebo Comparator: Placebo; Receive intravenous infusion of saline.	Other: Placebo; Receive intravenous infusion saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasodilation	Difference in circumference (in millimeter) of intra - and extracranial blood vessels before and after GLP-1 or placebo infusion, measured by transcranial doppler and ultrasound (Derma scan) at 10 specific time points (-10, 10, 20, 30, 40, 50, 60, 80, 100, and 120 minutes)	120 minutes
Headache intensity	Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	Blood pressure (systolic and diastolic) in mmhg will be measured every 10 minutes	120 minutes
Facial skin perfusion	Non-invasive measuring of facial skin perfusion by laser speckle contrast imager.	120 minutes
Heart rate	heart rate will be measured every 10 minutes	120 minutes
Plasma glucose	Plasma glucose will be measured using (mmol/L) a ABL Radiometer, Denmark Blood-gas analyser	120 minutes

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 15, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: H-19037051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No