The Effect of Glucagon on Cerebral Glucose Metabolism in Healthy Humans
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cerebral metabolic rate of glucose (CMRglc), acute effect (part C)
研究概览
简要总结
This is a pilot study in which the investigators will investigate the effect of exogenous glucagon on cerebral glucose metabolism in healthy humans.
Participants will participate in either part C or part D of the study, and each participant will participate in three study days. During a study day the participant will receive an intravenous infusion of either glucagon, glucose (in an adjustable rate to match to glucose concentrations achieved with the glucagon infusion) or saline. During each study day an 18F-flouro-deoxy-glucose (FDG) Positron Emission Tomography (PET)/Computed Tomography (CT) scan will be performed to quantify cerebral glucose metabolism during the first part (acute effect) of the glucagon/glucose/saline infusion (part C) or the last part (later effect) of the glucagon/glucose/saline infusion (part D).
详细描述
Participants in this study will participate in four visits; one screening visit and three study days.
Participants will be instructed to avoid strenuous exercise and alcohol intake two days prior to each experimental visit. Participants will arrive at the Department of Clinical Physiology and Nuclear Medicine after an overnight (>10 hours) fast (including coffee and medicine).
On all three study days, two peripheral venous catheters will be placed in the antecubital vein of each arm (one for the collection of blood samples and one for infusions). After two initial blood samples the infusion of either saline, glucagon or glucose will be started. The infusion rate of glucagon will be 10 ng/kg/min. The infusion rate of glucose will be adjustable, and adjusted to match the blood glucose levels achieved on the glucagon study day.
During the infusion of saline, glucagon or glucose a 18F-FDG PET/CT scan will be performed. The 18F-FDG PET/CT scan will be performed either in the beginning of the infusions (approximately 15-55 min after the start of infusion) (for participants in part C) or in the end of the infusions (approximately 150-190 min after the start of infusion) (for participants in part D).
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
- None
入排标准
- 年龄范围
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55 to 70 years
- •BMI under or equal to 30 kg/m2
- •Capable of understanding the participant information and signing the consent form
排除标准
- •Enrolment in other research projects that might interfere with the study
- •Diabetes diagnosis (type 1 and 2)
- •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
- •Impaired liver og kidney function
- •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
研究组 & 干预措施
Acute effect (part C): Glucagon, Saline and Glucose Clamp
The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Glucagon (part C) (Other)
Acute effect (part C): Glucagon, Saline and Glucose Clamp
The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Glucose clamp (part C) (Other)
Acute effect (part C): Glucagon, Saline and Glucose Clamp
The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Saline (part C) (Other)
Acute effect (part C): Saline, Glucagon and Glucose Clamp
The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Glucagon (part C) (Other)
Acute effect (part C): Saline, Glucagon and Glucose Clamp
The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Glucose clamp (part C) (Other)
Acute effect (part C): Glucagon, Glucose Clamp and Saline
The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Saline (part C) (Other)
Acute effect (part C): Saline, Glucagon and Glucose Clamp
The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Saline (part C) (Other)
Acute effect (part C): Glucagon, Glucose Clamp and Saline
The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Glucagon (part C) (Other)
Acute effect (part C): Glucagon, Glucose Clamp and Saline
The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline.
An 18F-FDG PET scan will be performed approximately 15-55 minutes after infusion start.
干预措施: Glucose clamp (part C) (Other)
Later effect (part D): Glucagon, Saline and Glucose Clamp
The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Glucagon (part D) (Other)
Later effect (part D): Glucagon, Saline and Glucose Clamp
The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Glucose clamp (part D) (Other)
Later effect (part D): Glucagon, Saline and Glucose Clamp
The arm includes three study days. Study day sequence: Glucagon, Saline and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Saline (part D) (Other)
Later effect (part D): Saline, Glucagon and Glucose Clamp
The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Glucagon (part D) (Other)
Later effect (part D): Saline, Glucagon and Glucose Clamp
The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Glucose clamp (part D) (Other)
Later effect (part D): Saline, Glucagon and Glucose Clamp
The arm includes three study days. Study day sequence: Saline, Glucagon and Glucose clamp.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Saline (part D) (Other)
Later effect (part D): Glucagon, Glucose Clamp and Saline
The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Glucagon (part D) (Other)
Later effect (part D): Glucagon, Glucose Clamp and Saline
The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Glucose clamp (part D) (Other)
Later effect (part D): Glucagon, Glucose Clamp and Saline
The arm includes three study days. Study day sequence: Glucagon, Glucose clamp and Saline.
An 18F-FDG PET scan will be performed approximately 150-190 minutes after infusion start.
干预措施: Saline (part D) (Other)
结局指标
主要结局
Cerebral metabolic rate of glucose (CMRglc), acute effect (part C)
时间窗: 15-55 minutes
CMRglc is calculated based on the 18F-FDG PET/CT scan.
次要结局
- Cerebral metabolic rate of glucose (CMRglc), later effect (part D)(150-190 minutes)
- Blood-brain glucose transfer capacity (Tmax), acute effect (part C)(15-55 minutes)
- Blood-brain glucose transfer capacity (Tmax), later effect (part D)(150-190 minutes)
- FDG net clearance (Ki), acute effect (part C)(15-55 minutes)
- FDG net clearance (Ki), later effect (part D)(150-190 minutes)
研究者
Nicolai Jacob Wewer Albrechtsen
Principal Investigator
University of Copenhagen