Glucagon-like Peptide 2 - a Glucose Dependent Glucagonotropic Hormone?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Glucagon secretion
研究概览
简要总结
Infusion of glucagon-like peptide 2 (GLP-2) during euglycaemia, hypoglycaemia and hyperglycaemia and evaluation of the effect on glucagon secretion in healthy subjects.
详细描述
This is a cross-over, randomized, double-blinded study in which 10 participants will undergo 6 experimental days each. The participants will have their plasma glucose clamped at either euglycaemia (fasting level), hypoglycemia (2,5 mmol/l) or hyperglycemia (10 mmol/l) during infusion of GLP-2 or saline (placebo)
The six days will be as follows:
- Euglycaemia + Placebo
- Euglycaemia + GLP-2
- Hyperglycaemia + Placebo
- Hyperglycaemia + GLP-2
- Hypoglycaemia + Placebo
- Hypoglycaemia + GLP-2
The primary endpoint will be levels of plasma glucagon. Secondary endpoint will be levels of GLP-1, GLP-2, Insulin/C-peptide, OXM, Amino acids, CCK, Gastrin, norepinephrine, bile acids, FGF-19/FGF-21. Secondary endpoints will also include ultrasound scan of the gallbladder.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian ethnicity
- •Body mass index (BMI): 18.5-27 kg/m2
- •Glycated haemoglobin (HbA1c) < 42 mmol/mol
- •Normal haemoglobin (8.3-10.5 mmol/l)
- •Informed and oral and written consent
排除标准
- •Prediabetes, type 1 diabetes or type 2 diabetes or first-degree relatives with type 1 or type 2 diabetes
- •Nephropathy (eGFR < 60 and/or albuminuria)
- •Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) > 2 × upper normal limit
- •Bilirubin > 25 μmol/l
- •Known intestinal disease or previous surgery of the intestines
- •Active or recent malignant disease
- •Treatment with medicine that cannot be paused for 12 hours
- •Any condition considered incompatible with participation by the investigators
结局指标
主要结局
Glucagon secretion
时间窗: 110 minutes
Assessed by difference in absolute plasma glucagon concentrations (measured in pmol/liter) and incremental (baseline-subtracted) area under curve (AUC) for plasma glucagon
次要结局
- FGF-21(110 minutes)
- Bile acids(110 minutes)
- Plasma glucose(110 minutes)
- GLP-2(110 minutes)
- OXM(110 minutes)
- Amino acids(110 minutes)
- Gastrin(110 minutes)
- Insulin(110 minutes)
- CCK(110 minutes)
- GLP-1(110 minutes)
- GIP(110 minutes)
- FGF-19(110 minutes)
- GH(110 minutes)
- Norepinephrine(110 minutes)
- CTX(110 minutes)
- Heart rate(110 minutes)
- P1NP(110 minutes)
- Gallbladder ultrasound(110 minutes)
- Glucose infusion(90 minutes)
- Blood pressure(110 minutes)
- C-peptide(110 minutes)
研究者
Filip Krag Knop
Clinical Professor
University Hospital, Gentofte, Copenhagen