Investigation of Vasodilation and Intensity of Headache Triggered by Glucagon-like Peptide-1 in Healthy Volunteers and Migraine Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Vasodilation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men/women.
- •Age 18 to 60 years old.
- •Weight 50 to 100 kg.
排除标准
- •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.
- •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.
- •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.
结局指标
主要结局
Vasodilation
时间窗: 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
时间窗: 12 hours
Headache intensity will be measured using Numerical rating scale (NRS) from ( 0 to 10 )
次要结局
- Plasma glucose(120 minutes)
- blood pressure(120 minutes)
- Facial skin perfusion(120 minutes)
- Heart rate(120 minutes)
研究者
Hashmat Ghanizada
Principal investigator
Danish Headache Center