Glucagon Responses Following Oral Glucose and Isoglycemic iv Glucose in Patients With Type 1 Diabetes - a Role for the Gastrointestinal Tract in Diabetic Hyperglucagonemia?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.
研究概览
简要总结
In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the GI tract) independently of the potentially very important regulation of glucagon secretion by endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon secretion in T1DM is highly needed in order to establish new intervention strategies in the future treatment of the growing numbers of T1DM patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
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
- •Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin
- •No residual beta-cell function (arginine test without increment in plasma C-peptide - see below)
- •BMI <30 kg/m2
- •Normal haemoglobin
- •Informed consent
排除标准
- •Residual beta-cell function (increment in plasma C-peptide during arginine test - see below)
- •Known liver disease or affected liver enzymes (ALAT/ASAT > 2 x upper normal limit)
- •Diabetic nephropathy (se-creatinin > 130 µM and/or albuminuria)
- •Proliferative diabetic retinopathy (anamnestic)
- •Treatment with medication that cannot be discontinued for 14 hours
结局指标
主要结局
Glucagon responses (as assessed by area under curve (AUC)) during 50-g oral glucose tolerance test (OGTT) and isoglycemic iv glucose infusion, respectively.
时间窗: months
次要结局
- Responses of glucagon-like peptide-1 (GLP-1), glucagon-like peptide-2 (GLP-2) and glucose-dependent insulinotropic polypeptide (GIP) as assessed by AUC during 50-g OGTT and isoglycemic iv glucose infusion, respectively.(months)
- GI-mediated glucose tolerance as assessed by the amount of glucose ingested as compared to the amount of glucose needed to mimic the OGTT curve during the iv glucose infusion.(Months)