The Role of Secretin on the Energy Homeostasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Duration of ad libitum meal
研究概览
简要总结
As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation. The mechanisms behind these regulatory effect of secretin on energy homeostasis are unclear,
详细描述
Secretin was - as the first hormone - identified in 19021, but was not isolated until the 1960s. Secretin is produced in and secreted form small intestinal S cells. In the 1970s, the primary endocrine effects of secretin were unequivocally confirmed, namely potentiation of bicarbonate and pepsin secretion from the pancreas as well as stimulation of bile production in the liver. In the 1990s, the biosynthesis of secretin was delineated and its receptor was discovered. In the 2000s the pancreatic regulation of intestinal pH was shown to be secretin-mediated. As of last year, new insight into the function of secretin was brought about as rodent studies showed secretin to possess potential body weight-regulating effects. In these studies, secretin was shown to increase non-shivering thermogenesis in brown adipose tissue (BAT), decrease meal size and promote meal discontinuation.
The primary aim of this study is to evaluate the effect of a 5-hour intravenous infusion with the naturally occurring hormone secretin on ad libitum food intake (primary endpoint) compared to a double-blinded placebo (isotonic saline) infusion in 25 healthy young males.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years
- •Body mass index between 18.5 and 27.5 kg/m2
- •Informed consent
- •Body weight above 50 kg
排除标准
- •Anaemia (blood haemoglobin below normal range)
- •Known liver disease and/or alanine aminotransferase and/or aspartate transaminase > 2 times upper normal values
- •Nephropathy (serum creatinine above normal range and/or albuminuria)
- •Clinically significant kidney function impairment or other laboratory findings leading to the diagnosis of clinically relevant disorders (thyroid dysfunction, anaemia etc)
- •Any physical or psychological condition that the investigators feel would interfere with trial participation
研究组 & 干预措施
Secretin
干预措施: Secretin (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Duration of ad libitum meal
时间窗: 300 minutes
Duration in minutes
Food intake on ad libitum meal
时间窗: 300 minutes
Kilojoule
次要结局
- Supraclavicular Brown adipose activity(-15 to 15 , 90 and 270 minutes)
- Heart rate(every 15 minutes from from -15 to 300 minutes)
- systolic blood pressure(every 15 minutes from from -15 to 300 minutes)
- resting energy expenditure(Baseline, 90 minutes and 270 minutes)
- Appetite and satiety sensations (assessed by VASs),(Every 15 minutes after infusion, until time-point 90, hereafter every 30 minutes)
- Gallbladder motility(Timepoint -30, 10,20,45,60,75,90,120,210,300 minutes)
- Water intake during ad libitum meal(300 minutes)
- Diastolic blood pressure(every 15 minutes from from -15 to 300 minutes)