GastroFlow: Investigation of the Gastrointestinal Blood Flow in Patients With Postprandial Hypotension
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood flow
研究概览
简要总结
This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with postprandial hypotension.
详细描述
Each participant will attend three independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2). Furthermore one day will be with handgrip exercise, without an infusion. Therefore the first two days are in randomized order.
MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines and pancreas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the PPH group
- •Inclusion Criteria:
- •Postprandial hypotension
- •Symptoms of postprandial hypotension
排除标准
- •Treatment with drugs that cannot be paused for 12 hours
- •Metallic implants that does not tolerate MRI
- •Any other disease or dysfunction that may disturb blood flow to the gut
- •Intake of more than 14 units of alcohol per week or abuse of drugs
- •Blood vessels that are not feasible for measuring flow in the MRI scanner
- •Low blood percent
- •Decreased kidney function
- •Decreased liver function
- •Claustrophobia
- •For the healthy group
- •Inclusion Criteria:
- •Matched by age, gender and BMI
- •Exclusion Criteria:
- •Postprandial hypotension
- •Metallic implants that does not tolerate MRI
- •Intake of more than 14 units of alcohol per week or abuse of drugs
- •Blood vessels that are not feasible for measuring flow in the MRI scanner
- •Low blood percent
- •Decreased kidney function
- •Decreased liver function
- •Claustrophobia
- •Autonomic dysfunction or other disease that cause changes in blood pressure during or after a meal
- •Intake of pharmaceutical products that influence the blood pressure
研究组 & 干预措施
Postprandial hypotension group
MRI scans of PPH patients. 3 interventions
干预措施: MRI + GIPR antagonist (Tool) (Other)
Postprandial hypotension group
MRI scans of PPH patients. 3 interventions
干预措施: MRI + hangrip (Other)
Postprandial hypotension group
MRI scans of PPH patients. 3 interventions
干预措施: Saline and oral glucose (Other)
Healthy matched controls
MRI scans of healthy controls. Crossover design three interventions.
干预措施: MRI + GIPR antagonist (Tool) (Other)
Healthy matched controls
MRI scans of healthy controls. Crossover design three interventions.
干预措施: MRI + hangrip (Other)
Healthy matched controls
MRI scans of healthy controls. Crossover design three interventions.
干预措施: Saline and oral glucose (Other)
结局指标
主要结局
Blood flow
时间窗: 145 minutes
Redistribution of splanchnic blood flow in the vessel mesenteric superior artery. Measured with functional MRI in ml/min
次要结局
- Blood flow(145 minutes)