Cerebral Glucose MetabolismGluCoMet_CDNCT06877208
The Effect of Glucagon on Cerebral Glucose Metabolism in Healthy Humans
A study testing Glucagon (part C), Glucose clamp (part C) and Saline (part C) in people with Cerebral Glucose Metabolism, run by Nicolai Jacob Wewer Albrechtsen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Glucose Metabolism
- What is being tested?
- Glucagon (part C), Glucose clamp (part C) and Saline (part C)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Mar 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55 to 70 years
- BMI under or equal to 30 kg/m2
- Capable of understanding the participant information and signing the consent form
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Copenhagen, 2400
About this study
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).
Read the detailed description
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).
- Conditions
- Cerebral Glucose Metabolism
- Being tested
- Glucagon (part C), Glucose clamp (part C), Saline (part C), Glucagon (part D), Glucose clamp (part D)
- Keywords
- Glucagon, 18F-FDG PET, Quantitative PET, Cerebral Glucose Metabolism, Blood-brain Glucose Transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon (part C)Other
90 minutes intravenous infusion with glucagon (infusion rate of 10 ng/kg/min).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Glucagon (part C); Other: Glucose clamp (part C); Other: Saline (part C) |
| 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. Receives: Other: Glucagon (part C); Other: Glucose clamp (part C); Other: Saline (part C) |
| 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. Receives: Other: Glucagon (part C); Other: Glucose clamp (part C); Other: Saline (part C) |
| 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. Receives: Other: Glucagon (part D); Other: Glucose clamp (part D); Other: Saline (part D) |
| 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. Receives: Other: Glucagon (part D); Other: Glucose clamp (part D); Other: Saline (part D) |
| 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. Receives: Other: Glucagon (part D); Other: Glucose clamp (part D); Other: Saline (part D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral metabolic rate of glucose (CMRglc), acute effect (part C)
CMRglc is calculated based on the 18F-FDG PET/CT scan.
Measured: 15-55 minutes
Secondary outcomes (5)
Cerebral metabolic rate of glucose (CMRglc), later effect (part D)
CMRglc is calculated based on the 18F-FDG PET/CT scan.
Measured: 150-190 minutes
Blood-brain glucose transfer capacity (Tmax), acute effect (part C)
Tmax is calculated based on the 18F-FDG PET/CT scan.
Measured: 15-55 minutes
Blood-brain glucose transfer capacity (Tmax), later effect (part D)
Tmax is calculated based on the 18F-FDG PET/CT scan.
Measured: 150-190 minutes
FDG net clearance (Ki), acute effect (part C)
Ki is calculated based on the 18F-FDG PET/CT scan.
Measured: 15-55 minutes
FDG net clearance (Ki), later effect (part D)
Ki is calculated based on the 18F-FDG PET/CT scan.
Measured: 150-190 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start18 Mar 2025
- Primary completionMay 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Glucose MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolai Jacob Wewer Albrechtsen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Sponsor-investigator, Nicolai Jacob Wewer Albrechtsen, University of Copenhagen
- Investigators
- Nicolai J Wewer Albrecthsen, MD PhD, Principal investigator, Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, DenmarkLisbeth J Marner, MD PhD, Study chair, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877208
- Sponsor's protocol ID
- GluCoMet_pilotCD
- Acronym
- GluCoMet_CD
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glucagon on Cerebral Glucose Metabolism in Healthy Humans
- ClinicalTrials.gov ID
- NCT06877208
- Acronym / sponsor ID
- GluCoMet_CD / GluCoMet_pilotCD
- Conditions
- Cerebral Glucose Metabolism
- Keywords
- Glucagon, 18F-FDG PET, Quantitative PET, Cerebral Glucose Metabolism, Blood-brain Glucose Transfer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nicolai Jacob Wewer AlbrechtsenUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acute effect (part C): Glucagon, Saline and Glucose Clamp | Experimental | Other: Glucagon (part C), Other: Glucose clamp (part C), Other: Saline (part C)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 | Other: Glucagon (part C), Other: Glucose clamp (part C), Other: Saline (part C)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 | Other: Glucagon (part C), Other: Glucose clamp (part C), Other: Saline (part C)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 | Other: Glucagon (part D), Other: Glucose clamp (part D), Other: Saline (part D)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. |
| Later effect (part D): Saline, Glucagon and Glucose Clamp | Experimental | Other: Glucagon (part D), Other: Glucose clamp (part D), Other: Saline (part D)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 | Other: Glucagon (part D), Other: Glucose clamp (part D), Other: Saline (part D)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. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55 to 70 years
- BMI under or equal to 30 kg/m2
- Capable of understanding the participant information and signing the consent form
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucagon (part C)90 minutes intravenous infusion with glucagon (infusion rate of 10 ng/kg/min). | Other | Acute effect (part C): Glucagon, Glucose Clamp and Saline, Acute effect (part C): Glucagon, Saline and Glucose Clamp, Acute effect (part C): Saline, Glucagon and Glucose Clamp |
| Glucose clamp (part C)90 minutes intravenous infusion of 20 % weight/volume glucose (in an ajustable rate to match the glucose levels achieved during the glucagon infusion). | Other | Acute effect (part C): Glucagon, Glucose Clamp and Saline, Acute effect (part C): Glucagon, Saline and Glucose Clamp, Acute effect (part C): Saline, Glucagon and Glucose Clamp |
| Saline (part C)90 minutes intravenous infusion with isotonic NaCl. | Other | Acute effect (part C): Glucagon, Glucose Clamp and Saline, Acute effect (part C): Glucagon, Saline and Glucose Clamp, Acute effect (part C): Saline, Glucagon and Glucose Clamp |
| Glucagon (part D)210 minutes intravenous infusion with glucagon (infusion rate of 10 ng/kg/min). | Other | Later effect (part D): Glucagon, Glucose Clamp and Saline, Later effect (part D): Glucagon, Saline and Glucose Clamp, Later effect (part D): Saline, Glucagon and Glucose Clamp |
| Glucose clamp (part D)210 minutes intravenous infusion of 20 % weight/volume glucose (in an ajustable rate to match the glucose levels achieved during the glucagon infusion). | Other | Later effect (part D): Glucagon, Glucose Clamp and Saline, Later effect (part D): Glucagon, Saline and Glucose Clamp, Later effect (part D): Saline, Glucagon and Glucose Clamp |
| Saline (part D)210 minutes intravenous infusion with isotonic NaCl. | Other | Later effect (part D): Glucagon, Glucose Clamp and Saline, Later effect (part D): Glucagon, Saline and Glucose Clamp, Later effect (part D): Saline, Glucagon and Glucose Clamp |
Primary outcome
Cerebral metabolic rate of glucose (CMRglc), acute effect (part C)
Time frame: 15-55 minutes
CMRglc is calculated based on the 18F-FDG PET/CT scan.
5 secondary outcomes
Cerebral metabolic rate of glucose (CMRglc), later effect (part D)
Time frame: 150-190 minutes
Blood-brain glucose transfer capacity (Tmax), acute effect (part C)
Time frame: 15-55 minutes
Blood-brain glucose transfer capacity (Tmax), later effect (part D)
Time frame: 150-190 minutes
FDG net clearance (Ki), acute effect (part C)
Time frame: 15-55 minutes
FDG net clearance (Ki), later effect (part D)
Time frame: 150-190 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolai J Wewer Albrecthsen, MD PhD principal investigator
Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Lisbeth J Marner, MD PhD study chair
University Hospital Bispebjerg and Frederiksberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucagon (part C), Glucose clamp (part C) and Saline (part C) in people with Cerebral Glucose Metabolism, run by Nicolai Jacob Wewer Albrechtsen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral metabolic rate of glucose (CMRglc), acute effect (part C) (time frame: 15-55 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.