The Glucagonotropic Effect of Amino Acids in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- bsAUC30
研究概览
简要总结
The objective of the study is to delineate the glucagonotropic signal exerted by selected amino acids in human subjects as well as the metabolic clearance rate of these amino acids after intravenous infusion
详细描述
After being informed about the study and the potential risks, each participant giving written informed consent will participate in six experimental days. The glucagonotropic effect and metabolic clearance of selected amino acids and saline (placebo), respectively, will be evaluated in 12 healthy individuals. After screening, each participant will undergo 6 double-blinded experimental days performed in randomized order. The experimental days will each last 75 minutes. The amino acids selected for the experiment are glutamine, arginine, alanine, leucine and proline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •normal fasting plasma glucose and glycated hemoglobin (HbA1c) < 42 mmol/mol
- •body mass index (BMI) between 18.5 and 25 kg/m2
- •Hemoglobin > 8.3 mmol/L
- •Age between 20 and 65 years
- •oral and written informed consent
排除标准
- •first-degree relatives with diabetes
- •fasting plasma triglycerides indicating dyslipidemia (> 2 mmol/L)
- •nephropathy (eGFR < 60 ml/min) and/or microalbuminuria (albumine/creatinine ratio > 30 microgram/mg)
- •liver disease and/or ALT and/or AST levels > 2 x upper normal reference limits.
- •signs of liver fibrosis and/or steatosis evaluated by transient elastography (CAP > 238 dB/min) and/or kPa > 6.0) and/or FIB-4 index > 1.45
- •regular use of prescription medication
- •use of dietary protein supplementation
- •any condition the investigator feels would interfere with trial completion
结局指标
主要结局
bsAUC30
时间窗: bsAUC is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min and 30 min
Baseline subtracted area under the curve for glucagon concentration during the first 30 minutes of the experiment
次要结局
- bsAUC60(bsAUC60 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min, 30 min and 60 min)
- AUC30(AUC30 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min and 30 min)
- peak glucagon concentration(measured between time 0 min and time 60 min)
- AUC60(AUC60 is calculated from blood samples drawn at times 0 min, 1 min, 2 min, 4 min, 6 min, 10 min, 15 min, 30 min and 60 min)
研究者
Malte Palm Suppli, MD
MD
University Hospital, Gentofte, Copenhagen