Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot study_A
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Tmax correlation
研究概览
简要总结
The aim of the study is to develop a non-invasive method for quantifying cerebral glucose metabolism by PET scans in humans. This method will be used in subsequent studies, where the effect of the pancreatic hormone glucagon on cerebral glucose metabolism will be studied.
The golden standard for quantifying cerebral glucose metabolism by PET scans is based on arterial blood sampling, which complicates research setup. This study will investigate if image derived measurements instead of arterial blood samples can be used to quantify cerebral glucose metabolism.
We will compare the calculations of cerebral glucose metabolism based on arterial blood samples and image derived measurements and hopefully these will correlate.
Healthy participants will be included, and each participant will participate in one study day, which includes intravenous administration of radioactively labelled glucose (18-FDG), arterial blood sampling and PET scans.
详细描述
Participants will arrive after a four hour fast. An arterial cannulation will be placed in the radial or brachial artery for blood sampling. A venous catheter will be placed in the antecubital vein for administration of 18-FDG. Blood glucose is measured.
Before administration of 18-FDG a "low dose" CT scan of the heart and brain will be performed.
At time 0 minutes 20 MBq 18-FDG will be administered, 10 minutes automatic blood sampling (from the arterial cannulation) will be started and a 10 minutes three part dynamic PET scan of the heart will be performed.
Approximately at time 20 minutes 180 MBq 18-FDG will be administered and a 40 minutes three part dynamic PET scan of the brain will be performed. During the first 10 minutes of the brain scan automatic blood sampling (from the arterial cannulation) will be performed and thereafter manual blood sampling will be performed every 5 minutes.
After the 40 minutes brain PET scan a 5 min post scan of the heart will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Body mass index <= 25 kg/m^2
排除标准
- •Enrolment in other research project that might interfere with the study
- •Diabetes diagnosis
- •Pregnancy or breastfeeding
- •Use of medications which, in the opinion of the investigator, may jeopardise participant's safety or compliance with the protocol
- •Diagnosis of psychiatric disorders, dementias, or any other neurological disorders that in the opinion of the investigator precludes compliance with the study protocol, evaluation of the results or represents an unacceptable risk for the participants safety
- •Severe claustrophobia
- •Cardiac problems including any of the following:
- •Classified as being in New York Heart Association (NYHA) class III or IV
- •Angina pectoris (chest pain) within the last 6 months
- •Acute myocardial infarction (heart attack) within last 2 years
- •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
结局指标
主要结局
Tmax correlation
时间窗: From administration of 180MBq 18-FDG and during the approximately first 15 min of the brain PET scan
Difference between the blood-brain glucose transfer capacity (Tmax) calculated based on the image derived input function and Tmax calculated based on the arterial input funcion.
次要结局
- CMRglc correlation(From administration of 180MBq 18-FDG and during the 40 min brain PET scan)
研究者
Nicolai Jacob Wewer Albrechtsen
Principal Investigator
University of Copenhagen