Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- Postprandial systolic blood pressure change (delta SBP)
研究概览
简要总结
The present study investigates the postprandial role of endogenous glucose-dependent insulinotropic polypeptide (GIP) on cardiovascular haemodynamics, hormone responses, and hypotensive symptoms during a tilt test.
详细描述
The study is an exploratory, randomised, placebo-controlled, double-blinded crossover study comprising four experimental days. Each experimental day consists of a mixed meal test or drinking water, a double-blinded continuous infusion of GIP(3-30)NH2 or placebo or GIP(1-42) or placebo, and three tilt tests. Sixteen healthy men and women will be included in the study.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •BMI between 18.5 and 29.9 kg/m2 (both included)
- •Informed consent
排除标准
- •Allergy or intolerance to ingredients included in the mixed meal
- •History of Orthostatic Hypotension (OH) or Postural Orthostatic Tachycardia Syndrome (POTS) or other autonomic dysfunction at the discretion of the investigators
- •Anaemia (haemoglobin below normal range <7.3 mmol/L for women and <8.3 mmol/L for men)
- •Kidney disease (estimated glomerular filtration rate (eGFR) <90 ml/min/1.73 m2) at screening
- •Known liver disease and/or elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at screening
- •Treatment with antihypertensives
- •Treatment with GLP-1RA (Glucagon-like Peptide-1 Receptor Agonist)
- •Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within two weeks before the first experimental day
- •Any ongoing medication that the investigator evaluates would interfere with trial participation
- •Any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
- •Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial
- •Alcohol/drug abuse as per discretion of the investigators
- •Pregnancy or breastfeeding
- •Participation in any other clinical trial during the study period
- •Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator
研究组 & 干预措施
GIP(3-30)NH2 + mixed meal test
Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min + mixed meal test
干预措施: GIP(3-30)NH2 / study tool (Other)
GIP(3-30)NH2 + mixed meal test
Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min + mixed meal test
干预措施: Saline (NaCl 0,9 %) (placebo) (Other)
Saline + mixed meal test
Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + mixed meal test
干预措施: GIP(3-30)NH2 / study tool (Other)
Saline + mixed meal test
Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + mixed meal test
干预措施: Saline (NaCl 0,9 %) (placebo) (Other)
GIP(1-42) + water
Intravenous infusion of GIP(1-42) in a concentration of 4,000 pmol/kg/min + intake of water
干预措施: GIP(1-42) (Other)
Saline + water
Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + intake of water
干预措施: Saline (NaCl 0,9 %) (placebo) (Other)
Saline + water
Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + intake of water
干预措施: GIP(1-42) (Other)
结局指标
主要结局
Postprandial systolic blood pressure change (delta SBP)
时间窗: From -35 to 50 minutes
The mean difference between postprandial systolic blood pressure-change (delta SBP) during tilt test following infusion of GIP(3-30)NH2 compared to infusion of placebo.
次要结局
未报告次要终点
研究者
lise wilki-kurtzhals
MD, PhD student
University Hospital, Gentofte, Copenhagen