Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)
研究概览
简要总结
This study will describe the interplay between the gut hormones GIP and CCK and their regulation of blood flow to the large vessels in patients with Postural Orthostatic Tachycardia Syndrome (POTS) and GIP, CCK and GLP-1 in healthy. This is addressed by hormone infusions during MR-scans of the abdomen and intake of oral glucose.
详细描述
Each participant will attend independent randomized experimental days with MR-scans during and intravenous infusions of hormones or placebo and ingestion of glucose or water. A continuous intravenous infusion of either GIP(3-30)NH2, CCK8- or saline for POTS-group or GIP(3-30)NH2, CCK-8, saline or exendin(9-39)NH2 in healthy is started while the participant lie in the scanner while scans, blood samples and questionnaires are repeated over the time course of 2 hours. At a specific timepoint the participants will ingest 75 g of glucose dissolved in 250 ml water.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •POTS patients:
- •Previously diagnosed with POTS in tilt test or active stand-test (either newly diagnosed within last 3 months or in new tilt test/active stand test during screenings visit)
- •Reproducible orthostatic intolerance with raise in HR on >30 bpm when standing within 10 minutes of change of supine to standing in age >19 years or >40 bpm in age 18-19 years.
- •POTS symptoms/orthostatic intolerance
- •Age 18-50
- •Waist ratio <180 cm
排除标准
- •Chronic illness
- •Metallic implants
- •Above 10 alcoholic drinks or week or substance abuse
- •Other types of sinus tachycardia or heart disease
- •Liverenzymes two times above normal values
- •Decreased kidney function eGFR <90 or elevated kreatinkinasis
- •Thyroid disease or TSH out of reference
- •Uncontrollable low or high blood pressure
- •Blood vessels that cannot be visualized on MR
- •Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours
- •Inclusion Criteria:
- •Age 18-50
- •Waist ratio <180 cm
- •Matched a POTS patient in age, sex and BMI
- •Exclusion Criteria:
- •Chronic illness
- •Metallic implants
- •Above 10 alcoholic drinks or week or substance abuse
- •POTS; other types of sinus tachycardia or heart disease
- •Liverenzymes two times above normal values
- •Decreased kidney function eGFR <90 or elevated kreatinkinasis
- •Thyroid disease or TSH out of reference
- •Uncontrollable low or high blood pressure, Orthostatic hypotension
- •Blood vessels that cannot be visualized on MR
- •Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours
研究组 & 干预措施
Saline
Saline infusion, oral glucose (POTS and healthy)
干预措施: Saline/Placebo (Other)
GIP antagonist
GIP(3-30)NH2 infusion, oral glucose (POTS and healthy)
干预措施: GIPR antagonist (Other)
GLP-1 antagonist
Exendin(9-39)NH2 infusion, oral glucose (only in healthy)
干预措施: GLP-1R antagonist (Other)
CCK agonist
CCK-8 infusion, oral glucose (POTS and healthy)
干预措施: CCK agonist (Other)
结局指标
主要结局
Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)
时间窗: Continuously for 80 minutes/during infusions
Blood flow in the superior mesenteric artery measured with MR ml/min
次要结局
- Blood flow in portal vein(Continuously for 80 minutes/during infusions)
- Blood Flow in celiac trunk(Continuously for 80 minutes/during infusions)
- Blood Flow in the hepatic artery(Continuously for 80 minutes/during infusions)
- Blood samples for hormones(Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes))
- Gastric emptying/Blood sample of paracetamol(Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes))
- Symptomscoring(Continously before and during the infusions (120 minutes))
- Blood samples for genes(One measurement at baseline visit)
- Blood sample for glucose(Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes))
- Blood samples for autoantibodies(One measurement at baseline visit)