Effect of Combination of the Gut Hormones Neurotensin and GLP-1 on Physiological Regulation of Appetite and Food Intake
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Ad-libitum food intake
研究概览
简要总结
Co-infusion of Neurotensin and GLP-1 Effects on Appetite and Food Intake.
详细描述
Neurotensin (NT), a gut hormone and neuropeptide, and GLP-1, as well a gut hormone, increases in circulation after bariatric surgery in rodents and humans and inhibit food intake in mice.
Studies in rodents have shown that a GLP-1 receptor agonist and long acting neurotensin inhibit food intake.
This study investigates whether the synergistic anorexic effects of neurotensin and GLP-1 agonism 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
- Double (Participant, Investigator)
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 humane serum albumine (HSA) or isotonic saline with HSA + neurotensin or isotonic saline with HSA + GLP-1) prepared by a designated colleague
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Above 18 years of age
- •Normal hemoglobin concentration
- •28<BMI<40 kg/m2
排除标准
- •Diabetes mellitus
- •Truncal vagotomy
- •Resection of intestine (apart from appendectomy)
- •Tobaccos use
- •Nephropathy (serum-creatinin>130 micromolar or/and albuminuria)
- •Liver disease (Alanine transaminase or/and aspartate transaminase>2 times normal range.)
- •Treatment with medication that cannot be paused in 12 hours
- •Allergy towards latex or plastic
- •Bleeding disorder
结局指标
主要结局
Ad-libitum food intake
时间窗: 120 min
Neurotensin (NT), saline, GLP-1 and GLP-1+Neurotensin will be infused on four occasions in random order, double blinded. After 2h of infusion 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
- Metabolomics(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Proteomics(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Appetite and gastrointestinal sensations(-60, -30, 0, 30, 60, 90, 120, 150 and 180 min)
- Plasma glucose(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Neurotensin(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- GLP-1(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Insulin(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- C-peptide(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Leptin(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Bile acids(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Ghrelin(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
- Peptide YY (PYY)(-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 165 and 180 min)
研究者
Birgitte Holst
Professor
University of Copenhagen