Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Lipoprotein production and clearance rate
研究概览
简要总结
- To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study A)
- To assess whether GLP-2 affects the release of preformed chylomicrons (study B)
详细描述
Study A: Using constant feeding with a nasoduodenal tube and stable isotope infusion, mathematical modelling will be utilised to measure lipoprotein production and clearance. The lipoproteins assessed will be apoB-100 from the liver and apoB-48 from the intestine.
StudyB: Volunteers will be given a liquid meal with retinyl palmitate (vitamin A) to label chylomicrons made from the meal. 7 hours later they will be given GLP-2 or placebo. Measurements of plasma and TRL(triglyceride rich lipoprotein) triglyceride and TRL retinyl palmitate will be carried out to see whether GLP-2 increases these parameters.
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)
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
- •Inclusion Criteria:
- •Men and women, aged 18 to 60 years
- •Body mass index 20 kg/m2 to 30 kg/m2
- •Hemoglobin above 130g/L.
- •Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test (OGTT)
排除标准
- •Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
- •Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180) or proliferative retinopathy
- •History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
- •Any history of ischemic heart disease or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
- •Abnormal liver or thyroid function tests
- •Current addiction to alcohol or substances of abuse as determined by the investigator.
- •Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- •Taking any prescription or non-prescription medications at the time of the study
- •Having donated blood three months prior to and three months post study procedures
- •A pregnancy test will be performed 1 to 3 days prior to each study in all female research participants. Those who test positive for pregnancy will be excluded.
研究组 & 干预措施
GLP=2
active treatment with a single dose of GLP-2 (1500mcg)
干预措施: GLP-2 (Drug)
Placebo
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Lipoprotein production and clearance rate
时间窗: 10 hours
ApoB 100 and ApoB 48 production and clearance
次要结局
- Plasma and TRL triglyceride and TRL retinyl palmitate(10 hours)