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| Name | Class |
|---|---|
| University Hospital Bispebjerg and Frederiksberg | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute effect (part C): Glucagon, Saline and Glucose Clamp | Experimental | 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. |
|
| Acute effect (part C): Saline, Glucagon and Glucose Clamp | Experimental | 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. |
|
| Acute effect (part C): Glucagon, Glucose Clamp and Saline | Experimental | 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. |
|
| Later effect (part D): Glucagon, Saline and Glucose Clamp | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucagon (part C) | Other | 90 minutes intravenous infusion with glucagon (infusion rate of 10 ng/kg/min). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral metabolic rate of glucose (CMRglc), acute effect (part C) | CMRglc is calculated based on the 18F-FDG PET/CT scan. | 15-55 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral metabolic rate of glucose (CMRglc), later effect (part D) | CMRglc is calculated based on the 18F-FDG PET/CT scan. | 150-190 minutes |
| Blood-brain glucose transfer capacity (Tmax), acute effect (part C) |
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Inclusion Criteria:
Exclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Nicolai J Wewer Albrecthsen, MD PhD | Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark | Principal Investigator |
| Lisbeth J Marner, MD PhD | University Hospital Bispebjerg and Frederiksberg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark | Copenhagen | 2400 | Denmark |
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| ID | Term |
|---|---|
| D005934 | Glucagon |
| D015309 | Glucose Clamp Technique |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Later effect (part D): Saline, Glucagon and Glucose Clamp | Experimental | 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. |
|
| Later effect (part D): Glucagon, Glucose Clamp and Saline | Experimental | 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. |
|
| Glucose clamp (part C) | Other | 90 minutes intravenous infusion of 20 % weight/volume glucose (in an ajustable rate to match the glucose levels achieved during the glucagon infusion). |
|
| Saline (part C) | Other | 90 minutes intravenous infusion with isotonic NaCl. |
|
| Glucagon (part D) | Other | 210 minutes intravenous infusion with glucagon (infusion rate of 10 ng/kg/min). |
|
| Glucose clamp (part D) | Other | 210 minutes intravenous infusion of 20 % weight/volume glucose (in an ajustable rate to match the glucose levels achieved during the glucagon infusion). |
|
| Saline (part D) | Other | 210 minutes intravenous infusion with isotonic NaCl. |
|
Tmax is calculated based on the 18F-FDG PET/CT scan.
| 15-55 minutes |
| Blood-brain glucose transfer capacity (Tmax), later effect (part D) | Tmax is calculated based on the 18F-FDG PET/CT scan. | 150-190 minutes |
| FDG net clearance (Ki), acute effect (part C) | Ki is calculated based on the 18F-FDG PET/CT scan. | 15-55 minutes |
| FDG net clearance (Ki), later effect (part D) | Ki is calculated based on the 18F-FDG PET/CT scan. | 150-190 minutes |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |