Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Glucagon infusion rate that increases plasma glucose
研究概览
简要总结
In this study the investigators will investigate the acute effects of increasing glucagon exposure on metabolic parameters in healthy participants.
Participants will participate in one study day. After initial baseline blood samples, a three-hour intravenous infusion with glucagon will be initiated. The infusion rate will be increased every 30 minutes.
详细描述
Ten participants with normal health will be included, and each participant will participate in one study day.
Participants will arrive after an overnight fast and will be placed in a hospital bed in a semi-recumbent position. In each antecubital vein an intravenous catheter will be placed; one for administration of glucagon and one for blood sampling.
Two baseline blood samples will be drawn before the glucagon infusion is started. The glucagon infusion rate will be increased every 30 minutes (infusion rates are 0,01 ng/kg/min, 0,1 ng/kg/min, 0,5 ng/kg/min, 1,0 ng/kg/min, 10 ng/kg/min and 50 ng/kg/min).
Blood samples for the analysis of plasma glucagon, glucose, insulin, C-peptide etc. will be drawn every 15 minutes.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of understanding the participant information and signing the consent form
- •Between 25 and 70 years of age at the time of screening
- •Body mass index (BMI) ≤ 25 kg/m2 at the time of screening
排除标准
- •Enrolment in other research projects that might interfere with the study
- •Diabetes diagnosis (type 1 and 2)
- •Pregnancy or breastfeeding
- •Use of medications which, in the opinion of the investigator, may jeopardise participant's safety or compliance with the protocol
- •Impaired liver function defined as either alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) ≥ 2 times normal values
- •Kidney disease defined as serum creatinine levels ≥ 126 μmol/L for male and ≥ 111 μmol/L for female
- •Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the range 90-150 mmHg for systolic and 50-100 mmHg for diastolic
- •Active or recent malignant disease
- •Current or history of severe alcohol use or drug/chemical abuse as per investigator's judgement
- •Any chronic disorders or severe diseases which, in the opinion of the investigator, might jeopardise participant's safety or compliance with the protocol
研究组 & 干预措施
Glucagon Infusion
干预措施: Glucagon (Other)
结局指标
主要结局
Glucagon infusion rate that increases plasma glucose
时间窗: 0-180 minutes
Glucagon infusion rate at which plasma glucose levels are significantly increased compared to baseline
次要结局
- Glucagon infusion rate that increases plasma cAMP(0-180 minutes)
- Glucagon infusion rate that decreases plasma amino acids(0-180 minutes)
- Glucagon infusion rate that affects plasma triglycerides(0-180 minutes)
- Glucagon infusion rate that affects plasma nonesterified fatty acids(0-180 minutes)
研究者
Nicolai Jacob Wewer Albrechtsen
Principal Investigator
University of Copenhagen