Endogenous Glucoseproduction in Patients With Type 2 Diabetes Mellitus During Oral Glucose and iv. Glucose Infusion
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
- Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC)
研究概览
简要总结
We want to investigate how lack of glucagon suppression during an oral glucose tolerance test in patients with type 2 diabetes contributes to patients postprandial hyperglycemia.
详细描述
Patients with type 2 diabetes mellitus (T2DM) are not able to suppress their glucagon secretion after a meal or after ingestion of glucose. Previous studies have shown that gastrointestinal hormones might play a role in this phenomenon. However, it has not yet been possible to determine whether this lack of glucagon suppression postprandially results in an increased endogenous glucose secretion, and thus is a factor in the patients postprandial hyperglycemia.
We aim to perform oral glucose tolerance tests and isoglycemic intravenous glucose infusions with and without a continuous glucagon infusion in patients with T2DM and healthy control subjects. The glucagon infusion is aiming at copying the inappropriate "physiological" glucagon response observed in patients with T2DM.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with T2DM
- •Caucasions above 35 years of age with diet and/or tablettreated T2DM of at -least three months (diagnosis acording to WHO)
- •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 35 years
- •Informed consent
排除标准
- •Inflammatory bowel disease
- •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
- •Patients with T2DM
- •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
Differences in Endogenous glucose production during the three days measured as total Area under the curve (tAUC)
时间窗: 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 and 240 min on all days.
calculated based on infusions of stable isotope marked glucose
次要结局
- Differences in incretin hormone levels during the three days measured as total Area under the curve (tAUC)(incretin hormone levels will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180, 240 min on all days.)
- Differences in gastrointestinal hormones during the three days measured as total Area under the curve (tAUC)(At the end of the study)
- Differences in glucagon during the three days measured as total Area under the curve (tAUC)(Glucagon will be measured at time points: -30,-15,0,10,20,30,50,70,90,120,150,180 and 240 min on all days.)
- differences in appetite, hunger, satiety between the three days(Satiety, hunger and appetite will be measured at time points:0,30,60,90,120,150,180, 240 min during each day.)
研究者
Asger Lund
MD
University Hospital, Gentofte, Copenhagen