Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Metabolic clearance rate of glucagon
研究概览
简要总结
The study aims to evaluate the elimination and degradation of glucagon in patients with type 2 diabetes compared to matched healthy subjects.
详细描述
In the present project the investigators wish to identify whether the elimination and degradation of glucagon differ between healthy control subjects and patients with type 2 diabetes. Furthermore, the investigators wish to examine whether obesity is an independent factor for altered glucagon metabolism. Thus, by examining glucagon elimination in obese subjects with and without type 2 diabetes and in lean subjects with and without type 2 diabetes the investigators will be able to describe the metabolic clearance rate (MCR) of glucagon in a broad spectrum of individuals with different levels of insulin resistance and beta cell dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patients with type 2 diabetes
- •Caucasians above 35 years of age with diet or/and metformin-treated type 2 diabetes of at least 3 month duration (diagnosed according to World Health Organization (WHO) criteria
- •BMI either below 27 or above 33 kg/m^2
- •Normal haemoglobin
- •Informed consent
- •Subjects with NGT
- •Caucasians above 35 years of age
- •BMI either below 27 or above 33 kg/m^2
- •Normal HbA1c (according to WHO criteria)
- •Normal haemoglobin
- •Informed consent
排除标准
- •Patients with type 2 diabetes
- •Inflammatory bowel disease
- •Operation within the last 3 months
- •Severe kidney disease (eGFR < 60 ml/min)
- •Severe liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2×normal values)
- •Pregnancy and/or breastfeeding
- •Age above 80 years
- •Any condition that the investigators feel would interfere with trial participation
- •Subjects with NGT
- •Prediabetes (impaired FPG or HbA1c above 42 mmol/mol)
- •First-degree relatives with diabetes
- •Inflammatory bowel disease
- •Intestinal resection
- •Severe kidney disease (eGFR < 60 ml/min)
- •Liver disease (ALA T and/or serum ASA T >2×normal values)
- •Pregnancy and/or breastfeeding
- •Age above 80 years Any condition that the investigators feel would interfere with trial participation
研究组 & 干预措施
Diabetic, obese subjects
Diabetic subjects with BMI > 33 kg/m^2
干预措施: Glucagon (Biological)
Healthy, obese subjects
Healthy subjects with BMI > 33 kg/m^2
干预措施: Glucagon (Biological)
Healthy, lean subjects
Healthy subjects with BMI < 27 kg/m^2
干预措施: Glucagon (Biological)
Diabetic, lean subjects
Diabetic subjects with BMI < 27 kg/m^2
干预措施: Glucagon (Biological)
结局指标
主要结局
Metabolic clearance rate of glucagon
时间窗: -30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes
次要结局
- Gut and pancreatic hormones(-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes)
- Blood glucose(-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes)
- Basic metabolic rate(-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes)
- Satiety, hunger, appetite - measured with visual analogue scales (VAS)(-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes)
- Half life of glucagon(-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes)
- The volume of distribution of glucagon(-30, -15, 0, 5, 10, 20, 50, 55, 60, 62, 64, 66, 68, 70, 75, 80, 85, 90, 120 minutes)
研究者
Asger Lund
Asger Lund, MD, PhD-student, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen