Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon Like Peptide-1 in Humans
- Conditions
- Headache, Migraine
- Interventions
- Other: PlaceboOther: GLP-1 peptide
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 43
- Healthy men/women.
- Age 18 to 60 years old.
- Weight 50 to 100 kg.
- 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
- Arm && Interventions
Group Intervention Description Placebo Placebo Receive intravenous infusion of saline. GLP-1 GLP-1 peptide Receive intravenous infusion of GLP-1.
- 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