NCT06208904Enrolling By Invitation不适用
The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
University Hospital, Gentofte, Copenhagen2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Nadir systolic blood pressure (mmHg)
研究概览
简要总结
The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)
详细描述
The study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the GIP receptor antagonist, GIP(3-30)NH2 (NH2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (MMT). Eighteen participants, men and women, with MMT confirmed PPH 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-85 years
- •History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
- •Informed consent
排除标准
- •Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories
- •Treatment with antihypertensives
- •Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within three months before screening visit
- •Allergy or intolerance to ingredients included in the mixed meal
- •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
- •Anaemia (haemoglobin below normal range <7.3 mmol/L for women and <8.3 mmol/L for men)
- •Moderate to severe loss of kidney function (estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m2) at screening
- •Known liver disease (except for simple steatosis) and/or elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at screening
- •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 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
结局指标
主要结局
Nadir systolic blood pressure (mmHg)
时间窗: 0-180 minutes
Nadir and time to nadir
Nadir systolic blood pressure (SBP) (mmHg)
时间窗: -45-0 minutes
Baseline
次要结局
- Systolic blood pressure (mmHg)(0-180 minutes)
- Diastolic blood pressure (mmHg)(0-180 minutes)
- Heart rate (beats/min)(0-180 minutes)
- Occurrence of PPH(0-180 minutes)
- Stroke volumen (ml)(0-180 minutes)
- Cardiac output (l/min)(0-180 minutes)
研究者
lise wilki-kurtzhals
Medical Doctor and PhD student
University Hospital, Gentofte, Copenhagen
研究点 (2)
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