Glucose MetabolismNCT06685146
The Glucose-Independent Effects of Exogenous Glucagon on Insulin Secretion and Cognitive Function in Healthy Subjects
A study testing Glucagon Infusion and Glucose clamp in people with Glucose Metabolism and Insulin Secretion, run by Nicolai Jacob Wewer Albrechtsen at 1 site in Denmark.
Trial summary
In this study the investigators will investigate the glucose-independent effects of exogenous glucagon on insulin secretion and cognitive function in healthy subjects. Subjects will participate in two study days. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism, Insulin Secretion
- What is being tested?
- Glucagon Infusion and Glucose clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2024to 21 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- A minimum of 7 years of schooling
Who cannot join
- 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
- 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
Show all 17Show fewer
- 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
- 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
- Inability to perform neuropsychological tests judged by the investigator (e.g. visual or auditory impairment or language barriers)
- 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 Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
Copenhagen, 2400
About this study
Official title: Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot Study
In this study the investigators will investigate the glucose-independent effects of exogenous glucagon on insulin secretion and cognitive function in healthy subjects.
Subjects will participate in two study days. The first study day is with a 240-minute infusion of glucagon and the second study day is with an infusion of glucose (clamped to match the glucose levels measured during the glucagon infusion). During the study day, blood samples will be drawn frequently and cognitive testing will be performed.
The investigators will investigate glucagon's glucose-independent effects on insulin secretion and cognitive function by comparing plasma measures of C-peptide and cognitive test scores between the glucagon study day and the glucose clamp study day.
Read the detailed description
Five-ten subjects with normal health will be included, and each subject will participate in two study days.
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 or glucose and one for blood sampling. The first study day will be the glucagon study day. The blood measurements of glucose from the glucagon study day will be used for clamping the glucose levels during the glucose clamp study day.
Baseline blood samples will be drawn. At time 0 minutes the infusion of glucagon or glucose will be initiated. Glucagon will be infused at a rate of 10ng/kg/min. Blood glucose will be measured every five minutes for the first approximately 2.5 hours, and thereafter every 10-15 minutes. During the glucose-clamp study day the infusion rate of glucose will be adjusted continuously to match the glucose levels measured on the glucagon study day.
Blood samples for the analysis of plasma glucagon, insulin, C-peptide etc. will be drawn every five minutes for the first 60 minutes, and thereafter every 15-30 minutes.
After approximately three hours cognitive testing will be performed. After four hours, the infusion of either glucagon or glucose will be terminated. The final blood samples will be drawn 15 and 30 minutes after termination of the infusion.
- Conditions
- Glucose Metabolism, Insulin Secretion
- Being tested
- Glucagon Infusion, Glucose clamp
- Keywords
- Glucagon, Glucose Metabolism, Cognition, Glucose clamp, Insulin secretion, C-peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon InfusionOther
A 240 minutes infusion of glucagon (10 ng/kg/min)
Glucose clampOther
A 240 minutes infusion of 20 % w/v glucose. The infusion rate of glucose will be adjusted continuously to match the levels of glucose measured on the glucagon study day.
| Study group | Role | What they receive |
|---|---|---|
| Glucagon infusion followed by glucose-clamp | Experimental | The first study day is a 240 minutes infusion of glucagon (10ng/kg/min). The second study day is a 240 minutes infusion of glucose (20% w/v). The infusion rate of glucose will be adjusted continuously to match the levels of glucose measured on the glucagon study day. Receives: Other: Glucagon Infusion; Other: Glucose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide (0-90 minutes)
Difference in plasma concentrations of C-peptide assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-90 minutes)
Secondary outcomes (19)
C-peptide to glucose ratio (0-90 minutes)
Difference in plasma concentration of C-peptide assessed as area under the curve divided by plasma concentration of glucose assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-90 minutes)
C-peptide to glucose ratio (0-240 minutes)
Difference in plasma concentration of C-peptide assessed as area under the curve divided by plasma concentration of glucose assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-240 minutes)
C-peptide (0-240 minutes)
Difference in plasma concentrations of C-peptide assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-240 minutes)
C-peptide (0 minutes-glucose peak)
Difference in plasma concentrations of C-peptide assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-time to plasma glucose peak concentration (assessed up to two hours))
C-peptide deconvolution (0-240 minutes)
Difference in deconvolution of plasma concentrations of C-peptide between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-240 minutes)
Insulin (0-90 minutes)
Difference in plasma concentrations of insulin assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-90 minutes)
Insulin (0-240 minutes)
Difference in plasma concentrations of insulin assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-240 minutes)
Time to glucagon peak
Time to glucagon peak on the glucagon study day
Measured: During intervention (0-240 minutes)
Time to glucagon steady state
Time to glucagon steady state on the glucagon study day
Measured: During intervention (0-240 minutes)
Glucagon concentration at steady state
Plasma glucagon steady state concentration on the glucagon infusion study day
Measured: During intervention (0-240 minutes)
Glucose (0-90 minutes)
Difference in plasma glucose assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-90 minutes)
Glucose (0-240 minutes)
Difference in plasma glucose assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-240 minutes)
Glucose peak
Difference in plasma glucose peak concentration between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-240 minutes)
Time to glucose peak
Difference in time to plasma glucose peak concentration between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-time to plasma glucose peak concentration (assessed up to two hours)
Glucose infused
Glucose (g) infused on the glucose clamp study day
Measured: During intervention (0-240 minutes)
cAMP (0-90 minutes)
Difference in plasma concentration of cAMP assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-90 minutes)
cAMP (0-240 minutes)
Difference in plasma concentration of cAMP assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (0-240 minutes)
cAMP (240-300 minutes)
Difference in plasma concentration of cAMP assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (240-300 minutes)
Cognitive function
Difference in cognitive function assessed as a composite score from the cognitive testing (SCIP testing) between the glucagon infusion study day and the glucose clamp study day
Measured: During intervention (180-240 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start8 Nov 2024
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicolai Jacob Wewer Albrechtsen
- Sponsor type
- University, hospital or other
- 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, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685146
- Sponsor's protocol ID
- GluCoMet_pilotB
- Status last verified
- Apr 2026
- First submitted
- 6 Nov 2024
- 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
- Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot Study
- ClinicalTrials.gov ID
- NCT06685146
- Acronym / sponsor ID
- GluCoMet_pilotB
- Conditions
- Glucose Metabolism, Insulin Secretion
- Keywords
- Glucagon, Glucose Metabolism, Cognition, Glucose clamp, Insulin secretion, C-peptide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nicolai Jacob Wewer AlbrechtsenUniversity, hospital or other
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 12 Nov 2024 (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.
In this study the investigators will investigate the glucose-independent effects of exogenous glucagon on insulin secretion and cognitive function in healthy subjects.
Subjects will participate in two study days. The first study day is with a 240-minute infusion of glucagon and the second study day is with an infusion of glucose (clamped to match the glucose levels measured during the glucagon infusion). During the study day, blood samples will be drawn frequently and cognitive testing will be performed.
The investigators will investigate glucagon's glucose-independent effects on insulin secretion and cognitive function by comparing plasma measures of C-peptide and cognitive test scores between the glucagon study day and the glucose clamp study day.
Detailed description
Five-ten subjects with normal health will be included, and each subject will participate in two study days.
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 or glucose and one for blood sampling. The first study day will be the glucagon study day. The blood measurements of glucose from the glucagon study day will be used for clamping the glucose levels during the glucose clamp study day.
Baseline blood samples will be drawn. At time 0 minutes the infusion of glucagon or glucose will be initiated. Glucagon will be infused at a rate of 10ng/kg/min. Blood glucose will be measured every five minutes for the first approximately 2.5 hours, and thereafter every 10-15 minutes. During the glucose-clamp study day the infusion rate of glucose will be adjusted continuously to match the glucose levels measured on the glucagon study day.
Blood samples for the analysis of plasma glucagon, insulin, C-peptide etc. will be drawn every five minutes for the first 60 minutes, and thereafter every 15-30 minutes.
After approximately three hours cognitive testing will be performed. After four hours, the infusion of either glucagon or glucose will be terminated. The final blood samples will be drawn 15 and 30 minutes after termination of the infusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucagon infusion followed by glucose-clamp | Experimental | Other: Glucagon Infusion, Other: Glucose clampThe first study day is a 240 minutes infusion of glucagon (10ng/kg/min). The second study day is a 240 minutes infusion of glucose (20% w/v). The infusion rate of glucose will be adjusted continuously to match the levels of glucose measured on the glucagon study day. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- A minimum of 7 years of schooling
Key exclusion criteria (17 listed)
- 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
- 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
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 InfusionA 240 minutes infusion of glucagon (10 ng/kg/min) | Other | Glucagon infusion followed by glucose-clamp |
| Glucose clampA 240 minutes infusion of 20 % w/v glucose. The infusion rate of glucose will be adjusted continuously to match the levels of glucose measured on the glucagon study day. | Other | Glucagon infusion followed by glucose-clamp |
Primary outcome
C-peptide (0-90 minutes)
Time frame: During intervention (0-90 minutes)
Difference in plasma concentrations of C-peptide assessed as area under the curve between the glucagon infusion study day and the glucose clamp study day
19 secondary outcomes
C-peptide to glucose ratio (0-90 minutes)
Time frame: During intervention (0-90 minutes)
C-peptide to glucose ratio (0-240 minutes)
Time frame: During intervention (0-240 minutes)
C-peptide (0-240 minutes)
Time frame: During intervention (0-240 minutes)
C-peptide (0 minutes-glucose peak)
Time frame: During intervention (0-time to plasma glucose peak concentration (assessed up to two hours))
C-peptide deconvolution (0-240 minutes)
Time frame: During intervention (0-240 minutes)
Insulin (0-90 minutes)
Time frame: During intervention (0-90 minutes)
Insulin (0-240 minutes)
Time frame: During intervention (0-240 minutes)
Time to glucagon peak
Time frame: During intervention (0-240 minutes)
Time to glucagon steady state
Time frame: During intervention (0-240 minutes)
Glucagon concentration at steady state
Time frame: During intervention (0-240 minutes)
Glucose (0-90 minutes)
Time frame: During intervention (0-90 minutes)
Glucose (0-240 minutes)
Time frame: During intervention (0-240 minutes)
Glucose peak
Time frame: During intervention (0-240 minutes)
Time to glucose peak
Time frame: During intervention (0-time to plasma glucose peak concentration (assessed up to two hours)
Glucose infused
Time frame: During intervention (0-240 minutes)
cAMP (0-90 minutes)
Time frame: During intervention (0-90 minutes)
cAMP (0-240 minutes)
Time frame: During intervention (0-240 minutes)
cAMP (240-300 minutes)
Time frame: During intervention (240-300 minutes)
Cognitive function
Time frame: During intervention (180-240 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
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 Infusion and Glucose clamp in people with Glucose Metabolism and Insulin Secretion, 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 4 inclusion and 17 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
C-peptide (0-90 minutes) (time frame: During intervention (0-90 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.