Investigating the Release of Stored Enteral Lipids in Response to a Single Subcutaneous Dose of Analogue Glucagon-like Peptide-2 in Humans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Release of enteral lipids in response to teduglutide
研究概览
简要总结
Some of the fat (triglyceride) from the food humans eat gets stored in the bowel. This triglyceride can then be released into the blood when another meal is consumed or in response to hormones. How the gut hormone glucagon-like peptide-2 (GLP-2) releases the triglyceride from the gut is not known. The research team in this study is interested in finding out how teduglutide (a degradation resistant form of GLP-2) releases stored triglyceride from the gut by studying samples from patients undergoing endoscopy and small bowel biopsy.
详细描述
The release of stored enteral lipids will be investigated in 30 patients undergoing upper gastrointestinal endoscopy and duodenal biopsy for clinical indications. Patients undergoing the procedure will be recruited. Participants will have a high fat liquid meal as breakfast. 5 hours later, participants will be randomly assigned to receive either a subcutaneous injection of placebo (n=15) or a subcutaneous injection of the Health Canada approved glucagon-like peptide-2 (GLP-2) analogue (teduglutide, Revestive®, Shire Canada)(n=15 different subjects). 1 hour later, a duodenal biopsy specimen will be obtained from 2-3 sample sites,snap frozen in dry ice and stored at -80°C for further analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Single-blinded study with participant blinded to treatment
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, aged 18 to 60 years requiring endoscopy and duodenal biopsies for clinical indications, with no contraindications to the procedure, as judged by Dr. Bookman of the Kensington Screening Clinic, Toronto, ON, Canada
排除标准
- •Patients with active inflammatory bowel disease
- •Patients with pre-existing Celiac disease, exocrine pancreatic insufficiency or small bowel malabsorption
- •Patients with active bowel malignancy
- •Patients with diabetes mellitus or known/ suspected motility disorders of the gut
- •Patients with decompensated liver disease
- •Patients on ezetimibe or bile acid sequestrants
- •Patients who are pregnant or breastfeeding.
- •Patients with renal disease
- •Patients on benzodiazepine
- •Unstable cardiac or respiratory disease
- •Any changes to medication in the preceding month
研究组 & 干预措施
Teduglutide
Teduglutide, up to 0.05mg/kg, subcutaneous, single dose
干预措施: Teduglutide (Drug)
Placebo
Placebo, subcutaneous, single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Release of enteral lipids in response to teduglutide
时间窗: 6 hours
To quantify the difference in amount of enteral lipids between GLP-2 and placebo treatment
次要结局
未报告次要终点