Involvement of Extrapancreatic Factors on Gastrointestinal-mediated Glucose Disposal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gastrointestinal-mediated glucose disposal (GIGD)
研究概览
简要总结
We want to investigate the mechanisms of extrapancreatic effects on gastrointestinal-mediated glucose disposal. In order to do so we will perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions in total pancreatectomised patients and in healthy controls.
详细描述
In the current project we wish to identify the possible contribution of extrapancreatic effects on gastrointestinal-mediated glucose disposal (GIGD). GIGD reflects the percentage of an individual's glucose disposal following oral glucose tolerance test (OGTT) which is caused by the oral route of glucose administration. In healthy subjects GIGD amounts to ~60%. GIGD describes not only the impact of the incretin effect (insulinotropic substances released upon intestinal stimulation) but includes all factors affecting glucose disposal differently during oral vs. iv administration of glucose (including neural reflexes, activation of afferent nerves in the intestinal mucosa, differences in glucagon secretion, hepatic glucose production and first-pass hepatic uptake of glucose, differences in portal and venous blood glucose concentrations and/or at the present unknown factors. It is likely that the incretin effect (pancreatic effect) constitutes a major contributor to GIGD, but so far it has been impossible to discriminate between pancreatic and extrapancreatic mechanisms underlying GIGD
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pancreatectomized patients
- •Caucasians above 18 years of age who have undergone total pancreatectomy
- •Normal haemoglobin
- •Informed consent Healthy Subjects
- •Normal fasting plasma glucose (FPG) and normal HbA1C (according to the World Health Organization (WHO) criteria)
- •Normal haemoglobin
- •Age above 18 years
- •Informed consent
排除标准
- •Pancreatectomized patients
- •Inflammatory bowel disease
- •Operation within the last 3 months
- •Ongoing chemotherapy or chemotherapy within the last 3 months
- •Nephropathy (serum creatinine >150 µM and/or albuminuria)
- •Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3×normal values)
- •Pregnancy and/or breastfeeding
- •Age above 80 years
- •Any condition that the investigator feels would interfere with trial participation Healthy Subjects
- •Diabetes mellitus (DM)
- •Prediabetes (impaired glucose tolerance and/or impaired FPG)
- •First degree relatives with DM
- •Inflammatory bowel disease
- •Intestinal resection and/or ostomy
- •Nephropathy (serum creatinine >150 µM and/or albuminuria
- •Liver disease (ALAT and/or serum ASAT >2×normal values)
- •Pregnancy and/or breastfeeding
- •Age above 80 years
- •Any condition that the investigator feels would interfere with trial participation
结局指标
主要结局
Gastrointestinal-mediated glucose disposal (GIGD)
时间窗: Calculated when the study days are all complete. approximately in 6month
GIGD will be calculated based on the amounts of glucose utilised during the two glucose administrations forms, OGTT and IIGI (GIGD (%) = 100%×(glucoseOGTT-glucoseIIGI)/glucoseOGTT)
plasma Glucagon
时间窗: Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.
次要结局
- endogenous glucose production(Endogenous glucose production will be calculated based on blood samples at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.)
- Satiety, hunger, appetite(Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180 min during each day.)
- Incretin Hormones(incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 min on all days.)
研究者
Asger Lund
MD, PhD-student
University Hospital, Gentofte, Copenhagen