The Effect of Neurotensin on Appetite, Food Intake, Blood Glucose Regulation, Hormone Secretion, and the Degradation of Neurotensin in Vivo
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Ad libitum food intake (ad libitum days)
研究概览
简要总结
Neurotensin (NT) is a gut peptide released postprandially from the small intestine. It is known to exert a range of enterogastrone effects and in animal models it reduces food intake when administered by parenteral routes.
This study investigates whether the anorexic effects of NT suggested by animal studies can be translated.
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, Investigator, Outcomes Assessor)
盲法说明
Participants will not be informed of the nature of the infusion they are administered on any of the study days. The investigator will be provided with an infusion (either isotonic saline with HSA or isotonic salin with HSA + neurotensin) prepared by a designated colleague
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age = or above 18 years
- •normal haemoglobin levels
- •informed consent
排除标准
- •Diabetes mellitus (fasting plasma glucose or HbA1c)
- •Familiy history of diabetes mellitus
- •Intestinal disease (incl e.g. inflammatory bowel disease and malabsorbtion)
- •Family history of inflammatory bowel disease
- •Previous intestinal resection
- •Body mass index (BMI) over 25 kg/m2
- •Nephropathy (S-creatinine> 130 μM)
- •Liver disease (ALAT and/or ASAT > 2 × upper normal limit)
结局指标
主要结局
Ad libitum food intake (ad libitum days)
时间窗: 60 min
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. After 1h of infusion an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
Ad libitum food intake (liquid meal + ad libitum days)
时间窗: 240 min
Neurotensin (NT) and saline will be infused on two occasions in random order, double blinded. 1h into the infusions a standardized liquid mixed meal will be ingested. After another 180 min an ad libitum meal will be served. When the meal is completed food intake will be determined by weighing the leftovers.
次要结局
- Appetite and gastrointestinal sensations (ad libitum days)(-60, -15, 15, 30, 60, 90, 120 min)
- Appetite and gastrointestinal sensations (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Plasma glucose (ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min)
- Plasma glucose (liquid meal + ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min)
- Neurotensin (ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min)
- Neurotensin (liquid meal + ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 240 min)
- Insulin (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Bile acids (ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min)
- Glucose-dependent insulinotropic polypeptide (GIP) (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Peptide YY (PYY) (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Paracetamol (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Pancreatic polypeptide (PP) (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Pancreatic polypeptide (PP) (ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min)
- Cholecystokinin (CCK) (ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min)
- Cholecystokinin (CCK) (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- bile acids (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Ghrelin (ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min)
- Ghrelin (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
- Glucagon-like peptide-1 (GLP-1) (ad libitum days)(-60, -30, -15, -1, 0- , 15, 30, 45, 60, 75, 90, 105, 120 min)
- Glucagon-like peptide-1 (GLP-1) (liquid meal + ad libitum days)(-60, -15, 15, 60, 90, 120, 150, 180, 210, 240 min)
研究者
Simon Veedfald
Principal investigator
University of Copenhagen