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

Not Applicable

• Conditions: Headache, Migraine

• Registration Number: NCT04232605
• Lead Sponsor: Danish Headache Center

Brief Summary

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.

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 Timeline

• Status Verified: 2020-01
• Study Start: 2020-01-09
• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-15
• Last Update Submitted: 2020-01-15
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Vasodilation	120 minutes	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)
Headache intensity	12 hours	Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dansk Hovedpinecenter; 🇩🇰 Glostrup, Denmark