The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Plasma concentrations of Glucagon
研究概览
简要总结
The study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine.
The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian ethnicity
- •Body mass index (BMI) 20-27 kg/m^2
- •Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
- •Informed and written consent
排除标准
- •Late microvascular complications except mild nonproliferative retinopathy
- •Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) > 2 times normal values) or history of hepatobiliary disorder
- •Treatment with any glucose-lowering drugs
- •Active or recent (within 5 years) malignant disease
- •Active tobacco smoking/use
- •Any condition considered incompatible with participation by the investigators.
研究组 & 干预措施
Saline
Intravenous administration of saline for 90 minutes.
干预措施: Placebo (saline) (Other)
GIP
Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes.
干预措施: GIP (Drug)
Alanine
Intravenous administration of alanine for 90 minutes (28 umol/kg/min).
干预措施: Alanine (Drug)
GIP + Alanine
Intravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes.
干预措施: GIP + alanine (Drug)
结局指标
主要结局
Plasma concentrations of Glucagon
时间窗: Timepoint -30 to 90 minutes
Baseline-corrected area under the curve (bsAUC)
次要结局
- Serum concentration of C-peptid(Timepoint -30 to 90 minutes)
- Circulating levels of total amino acids(Timepoint -30 to 90 minutes)
- Circulating levels of P1NP(Timepoint -30 to 90 minutes)
- Pulse(Timepoint -30, 0, 30, 60, 90)
- Plasma concentration of GIP(Timepoint -30 to 90 minutes)
- Blood pressure(Timepoint -30, 0, 30, 60, 90)
- Plasma concentration of glucose(Timepoint -30 to 90 minutes)
- Circulating levels of individual amino acids(Timepoint -30 to 90 minutes)
- Serum concentration of Insulin(Timepoint -30 to 90 minutes)
- Lipid profile(Timepoint -30 to 90 minutes)
- Circulating levels of CTx(Timepoint -30 to 90 minutes)
研究者
Filip Krag Knop
MD PhD, Professor
University Hospital, Gentofte, Copenhagen