NCT06189001已完成不适用
The Role of Oxytocin-receptor Signalling in Physiological Regulation of Eating Behaviour in Individuals with Obesity
University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Ad libitum food intake
研究概览
简要总结
The present study evaluates appetite, glucose metabolism, gastrointestinal motility and energy expenditure in men and women with obesity (BMI 30-40 kg/m2) under oxytocin exposure compared to placebo.
详细描述
In a randomised, double-blind, placebo-controlled, crossover fashion, 24 participants will complete two experimental days (A and B) including a mixed meal test and an ad libitum meal test. The procedures during the two experimental days are similar except for intravenous infusion of oxytocin on experimental day A and placebo (saline) on experimental day B, respectively. On experimental days, oxytocin or placebo infusion will be started at timepoint -60 minutes. At timepoint 0 minutes, participants will ingest a liquid mixed meal. After 190 minutes, participants are served an ad libitum meal followed by ad libitum snacks.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •BMI between 30 and 40 kg/m2 (both included)
- •Percentage body fat (BF%) ≥25 for men and ≥32 for women (assessed by bioelectrical impedance analysis)
- •Informed oral and written consent
排除标准
- •Anaemia (haemoglobin below normal range)
- •Alanine aminotransferase (ALT) >2 times normal values
- •History of hepatobiliary and/or gastrointestinal disorder(s)
- •Kidney disease (serum creatinine above normal range and/or urine albumin-creatinine ratio (uACR) >30 mg/g confirmed by two measures)
- •Previous gastric or intestinal resection, cholecystectomy and/or any major intra-abdominal surgery (including bariatric surgery)
- •Previous pancreatic disease and/or neoplasia
- •Regular tobacco smoking and/or use of other nicotine products
- •Glycated haemoglobin (HbA1c) ≥48 and/or type 1 diabetes or type 2 diabetes requiring medical treatment
- •Pituitary gland disorders
- •Initiation of special diets, lifestyle changes and/or weight loss >5% of total body weight within three months prior to or during study period
- •Pregnancy or breastfeeding
- •Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds for men and ≥0.46 seconds for women)
- •Any physical or psychological condition or ongoing medication the investigator group suspect would interfere with trial participation
研究组 & 干预措施
Oxytocin
Experimental
Intravenous oxytocin 0.2 IU/minute for 300 minutes Approx. 500 ml
干预措施: Oxytocin (Drug)
Placebo
Other
intravenous saline (0.9% NaCl) infusion for 300 minutes Approx. 500 ml
干预措施: Placebo (saline) (Other)
结局指标
主要结局
Ad libitum food intake
时间窗: Timepoint 190-220 minutes
Amount consumed (kcal)
次要结局
- Heart rate(Timepoint -75 to 185 minutes and timpoint 240 minutes)
- Plasma concentrations of sodium(Timepoint -95 and 235 minutes)
- Sensations of hunger(Timepoint -100 to 160 minutes)
- Gastric emptying (paracetamol absorption method)(Timepoint -95 to 180 minutes)
- Water intake during ad libitum meal(Timepoint 190-220 minutes)
- Blood pressure(Timepoint -75 to 185 minutes and timpoint 240 minutes)
- Plasma concentrations of creatinine(Timepoint -95 and 235 minutes)
- Plasma concentrations of potassium(Timepoint -95 and 235 minutes)
- Circulating levels of high-sensitive C-reactive protein (hsCRP)(Timepoint -95 and 235 minutes)
- Circulating levels of C-reactive protein (hsCRP)(Timepoint -95 and 235 minutes)
- Sensations of nausea(Timepoint -100 to 160 minutes)
- Sensations of prospective food intake(Timepoint -100 to 160 minutes)
- Sensations of thirst(Timepoint -100 to 160 minutes)
- Sensations of comfort(Timepoint -100 to 160 minutes)
- Composite appetite score(Timepoint -100 to 160)
- Serum concentrations of insulin(Timepoint -95 to 180 minutes)
- Serum concentrations of C-peptide(Timepoint -95 to 180 minutes)
- Beta cell function (C-peptide/glucose-ratio)(Timepoint -95 to 180 minutes)
- Ad libitum food intake(Timepoint 190-220 minutes)
- Gallbladder volume (ml)(Timepoint -120 to 180 minutes)
- Gallbladder ejection fraction (%)(Timepoint -120 to 180 minutes)
- Sensations of satiety(Timepoint -100 to 160 minutes)
- Sensations of fullness(Timepoint -100 to 160 minutes)
- Plasma concentrations of glucose(Timepoint -95 to 180 minutes)
- Plasma concentrations of cholecystokinin(Timepoint -95 to 180 minutes)
- Energy expenditure (indirect calorimetry)(Timepoint -90 to 150 minutes)
- Snacking (ad libitum snack test)(Timepoint 225-235 minutes)
- Plasma concentrations of GLP-1(Timepoint -95 to 180 minutes)
- Plasma concentrations of peptide YY(Timepoint -95 to 180 minutes)
- Plasma concentrations of secretin(Timepoint -95 to 180 minutes)
- Circulating levels of P1NP(Timepoint -95 to 180 minutes)
- Gallbladder volume(Timepoint -120 to 180 minutes)
- Plasma concentrations of glucagon(Timepoint -95 to 180 minutes)
- Plasma concentrations of GIP(Timepoint -95 to 180 minutes)
- Plasma concentrations of leptin(Timepoint -95 to 180 minutes)
- Plasma concentrations of ghrelin(Timepoint -95 to 180 minutes)
- Circulating levels of total amino acids(Timepoint -95 to 180 minutes)
- Lipid profile(Timepoint -95 to 180 minutes)
- Circulating levels of CTx(Timepoint -95 to 180 minutes)
- Circulating levels of PTH(Timepoint -95 to 180 minutes)
- Circulating levels of calcium(Timepoint -95 to 180 minutes)
- Desire for specific foods(Timepoint -100 to 160 minutes)
- Duration of ad libitum meal(Timepoint 190-220 minutes)
- Happiness (Oxford Happiness Questionnaire (translated to Danish))(Timepoint -65 and 160 minutes)
研究者
Filip Krag Knop
Professor, MD, PhD
University Hospital, Gentofte, Copenhagen
研究点 (1)
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