Neurotensin Infusions in Healthy Individuals - Effects on Appetite, Food Intake, Hormone Secretions and Cardiovascular Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Food intake
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.
In this study, after a 1h baseline period, three doses (2.5, 5.0 and 7.5pmol/kg/min) of NT will be administered in sequence each infusion lasting 1h. On a placebo day saline will be infused similarly 1h infusions. During the final infusion (7.5pmol/kg/min) an ad libitum meal will be ingested. During the experiments blood samples will be collected and subjective perceptions recorded using validated visual analogue scales.
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
Double blinded. Neither the investigators performing the experiments or the participants know the nature of the intervention on the two study days.
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
Food intake
时间窗: From time point t=190-220 minutes
The amount of food ingested over 30 minutes will be determined.
次要结局
- Hunger(-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes)
- Satiation(-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes)
- Fullness(-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes)
- Prospective food intake(-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes)
- Comfort(-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes)
- Thirst(-45, -15, 15, 45, 75, 105, 135, 165, 220, 250 minutes)
- Neurotensin(-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes)
- Pancreatic polypeptide(-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes)
- Blood pressure(-60 to 250 minutes)
- Glucagon(-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes)
- insulin and C-peptide(-60, -30, -15, 0, 15, 30, 60, 75, 90, 120, 135, 150, 180, 220 minutes)
- Heart rate(-60 to 250 minutes)
研究者
Simon Veedfald
Primary investigator
University of Copenhagen