Investigating the Plasma Lipoprotein 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
- 10
- 试验地点
- 1
- 主要终点
- Lipoprotein 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 evaluating how blood lipoproteins respond to teduglutide in healthy individuals.
详细描述
The lipoprotein response will be performed in 15 healthy individuals recruited by newspaper advertisements. Each subject will be their own control, receiving both placebo and teduglutide, administered on separate occasions. A member of the study team will explain the study in detail on visit 1, and if the individual is interested in participating, informed consent will be obtained and preliminary screening will occur on visit 2. On visit 3 & 4 participants will receive a high fat liquid meal after an overnight fast. Hourly blood samples will be taken for 5 hours, followed by randomized assignment to receive either subcutaneous placebo or teduglutide at visit 3 and the opposite treatment at visit 4. Following the injection, blood samples will be taken every 15 minutes for the first hour and every 30 minutes for the subsequent 3 hours.
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
- 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
- 是
入选标准
- •Men and women, aged 18 to 60 years.
- •Body mass index 20 to 27 kg/m2
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
Lipoprotein response to teduglutide
时间窗: 8 hours
To quantify the plasma lipoprotein response to teduglutide (GLP-2 analogue) injection in healthy individuals
次要结局
未报告次要终点