Glucose MetabolismNCT07350512
Investigating the Acute Effects of Increasing Alanine Exposure in Healthy Participants
A study testing alanine in people with Glucose Metabolism and Glucagon, run by Nicolai Jacob Wewer Albrechtsen at 1 site in Denmark.
Trial summary
In this study the investigators will investigate the acute effects of increasing alanine exposure on metabolic parameters in healthy participants. Participants will participate in one study day. After initial baseline blood samples, a three-hour intravenous infusion with glucagon will be initiated. 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, Glucagon
- What is being tested?
- alanine
- 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
- 20 Jan 2026to 20 Jan 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 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
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
- 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
Show all 10Show fewer
- 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. Contact the study team or a site near you to ask about taking part.
Elvar Már Sturlaugsson Jóhönnuson, Stud. Med. contact
Denmark1 site
Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Copenhagen
Sophie BB Johnsen, MD, 004521205944, sophie.betty.brock.johnsen.01@regionh.dk
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 acute effects of increasing alanine exposure on metabolic parameters in healthy participants.
Participants will participate in one study day. After initial baseline blood samples, a three-hour intravenous infusion with glucagon will be initiated. The infusion rate will be increased every 30 minutes.
Read the detailed description
Two peripheral catheters will be placed in the antecubital vein of each arm for infusion of L-alanine and blood sampling respectively. The infusion rate of alanine will start at 1.4 μmol/kg/min and increase every 30 minutes over a 3-hour period, up to a maximum of 28 μmol/kg/min. The study day will last approximately 4 hours, and a maximal blood volume of 130 ml will be collected. Blood samples for the analysis of plasma glucagon, glucose, insulin, C-peptide etc. will be drawn every 15 minutes.
- Conditions
- Glucose Metabolism, Glucagon
- Being tested
- alanine
- Keywords
- Alanine, glucagon, glucose metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alanineOther
A three-hour intravenous infusion with alanine with increasing infusion rate (from 1.4 μmol/kg/min and to 28 μmol/kg/min)
| Study group | Role | What they receive |
|---|---|---|
| Alanine infusion | Experimental | Not described Receives: Other: alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Threshold alanine infusion rate for stimulation of plasma glucagon
Lowest alanine infusion rate (µmol/kg/min) at which plasma glucagon concentration is significantly higher than baseline during a 3-hour stepwise alanine infusion (six 30-minute steps from 1.4 to 28 µmol/kg/min).
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Secondary outcomes (9)
Change in plasma glucose during stepwise alanine infusion
Plasma glucose concentration (mmol/L) measured at baseline and every 30 minutes during a 3-hour stepwise alanine infusion (1.4-28 µmol/kg/min), analyzed as absolute values and change from baseline.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma follicle-stimulating hormone (FSH) during stepwise alanine infusion
Plasma follicle-stimulating hormone (FSH) concentration (IU/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to explore acute effects on pituitary gonadotropin secretion.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma luteinizing hormone (LH) during stepwise alanine infusion
Plasma luteinizing hormone (LH) concentration (IU/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to explore acute effects on pituitary gonadotropin secretion.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma cortisol during stepwise alanine infusion
Plasma cortisol concentration (nmol/L) measured at baseline and every 60 minutes during the 3-hour stepwise alanine infusion to assess activation of the hypothalamic-pituitary-adrenal axis.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma triglycerides during stepwise alanine infusion
Plasma triglyceride concentration (mmol/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to evaluate acute effects on lipid metabolism.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma urea during stepwise alanine infusion
Plasma urea (carbamide) concentration (mmol/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to assess short-term effects on nitrogen metabolism.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma alanine aminotransferase (ALAT) during stepwise alanine infusion
Plasma alanine aminotransferase (ALAT/ALT) activity (U/L) measured at baseline and at the end of the 3-hour stepwise alanine infusion to assess acute changes in liver enzyme levels.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma C-peptide during stepwise alanine infusion
Plasma C-peptide concentration (pmol/L) measured at baseline and every 30 minutes during a 3-hour stepwise alanine infusion, analyzed as absolute values and change from baseline.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma insulin during stepwise alanine infusion
Plasma insulin concentration (pmol/L) measured at baseline and every 30 minutes during a 3-hour stepwise alanine infusion, analyzed as absolute values and change from baseline.
Measured: Baseline and every 30 minutes during the 0-180 min infusion period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion20 Jan 2027 (estimated)
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 (estimated)
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 Jacob Wewer Albrechtsen, MD PhD, Principal investigator, Department of Clinical Biochemistry, Copenhagen University Hospital - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350512
- Sponsor's protocol ID
- GluCoMet_stepwise alanine
- Status last verified
- Dec 2025
- First submitted
- 9 Jan 2026
- Last updated
- 20 Jan 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 20 Jan 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
- NCT07350512
- Acronym / sponsor ID
- GluCoMet_stepwise alanine
- Conditions
- Glucose Metabolism, Glucagon
- Keywords
- Alanine, glucagon, glucose metabolism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nicolai Jacob Wewer AlbrechtsenUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 20 Jan 2027 (estimated)
- First posted
- 20 Jan 2026 (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 acute effects of increasing alanine exposure on metabolic parameters in healthy participants.
Participants will participate in one study day. After initial baseline blood samples, a three-hour intravenous infusion with glucagon will be initiated. The infusion rate will be increased every 30 minutes.
Detailed description
Two peripheral catheters will be placed in the antecubital vein of each arm for infusion of L-alanine and blood sampling respectively. The infusion rate of alanine will start at 1.4 μmol/kg/min and increase every 30 minutes over a 3-hour period, up to a maximum of 28 μmol/kg/min. The study day will last approximately 4 hours, and a maximal blood volume of 130 ml will be collected. Blood samples for the analysis of plasma glucagon, glucose, insulin, C-peptide etc. will be drawn every 15 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alanine infusion | Experimental | Other: alanine |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
Key exclusion criteria (10 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
- Impaired liver function defined as either alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) ≥ 2 times normal values
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 |
|---|---|---|
| alanineA three-hour intravenous infusion with alanine with increasing infusion rate (from 1.4 μmol/kg/min and to 28 μmol/kg/min) | Other | Alanine infusion |
Primary outcome
Threshold alanine infusion rate for stimulation of plasma glucagon
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Lowest alanine infusion rate (µmol/kg/min) at which plasma glucagon concentration is significantly higher than baseline during a 3-hour stepwise alanine infusion (six 30-minute steps from 1.4 to 28 µmol/kg/min).
9 secondary outcomes
Change in plasma glucose during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma follicle-stimulating hormone (FSH) during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma luteinizing hormone (LH) during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma cortisol during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma triglycerides during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma urea during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma alanine aminotransferase (ALAT) during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma C-peptide during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
Change in plasma insulin during stepwise alanine infusion
Time frame: Baseline and every 30 minutes during the 0-180 min infusion period.
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 20 Jan 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.
Elvar Már Sturlaugsson Jóhönnuson, Stud. Med. contact
Nicolai Jacob Wewer Albrechtsen, 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 alanine in people with Glucose Metabolism and Glucagon, 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 10 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: opening soon, as of the sponsor's last update on 20 Jan 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?
Contact Elvar Már Sturlaugsson Jóhönnuson, Stud. Med. (21205944 Ext. 0045, elvar.mar.sturlaugsson@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Threshold alanine infusion rate for stimulation of plasma glucagon (time frame: Baseline and every 30 minutes during the 0-180 min infusion period.). 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 20 Jan 2026.