Cerebral Glucose MetabolismNCT06647368
Development of a Non-invasive Method for Quantifying Cerebral Glucose Metabolism for Studying the Effect of Glucagon in Humans
A study testing PET with 18-FDG in people with Cerebral Glucose Metabolism, run by Nicolai Jacob Wewer Albrechtsen at 1 site in Denmark.
Trial summary
The aim of the study is to develop a non-invasive method for quantifying cerebral glucose metabolism by PET scans in humans. This method will be used in subsequent studies, where the effect of the pancreatic hormone glucagon on cerebral glucose metabolism will be studied. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Glucose Metabolism
- What is being tested?
- PET with 18-FDG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Oct 2024to 17 Dec 2024
- 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
- Body mass index <= 25 kg/m^2
Who cannot join
- Enrolment in other research project that might interfere with the study
- Diabetes diagnosis
- 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
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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. Contact the study team or a site near you to ask about taking part.
Sasha Alexandra S Kjeldsen, MSc PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Physiology and Nuclear Medicine, University of Copenhagen - Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
Copenhagen, 2400
Lisbeth Marner, MD PhD, 004538635530, lisbeth.marner@regionh.dk
About this study
Official title: Investigating the Effect of Glucagon on Cognitive Function and Cerebral Glucose Metabolism in Humans: A Pilot study_A
The aim of the study is to develop a non-invasive method for quantifying cerebral glucose metabolism by PET scans in humans. This method will be used in subsequent studies, where the effect of the pancreatic hormone glucagon on cerebral glucose metabolism will be studied.
The golden standard for quantifying cerebral glucose metabolism by PET scans is based on arterial blood sampling, which complicates research setup. This study will investigate if image derived measurements instead of arterial blood samples can be used to quantify cerebral glucose metabolism.
Read more
We will compare the calculations of cerebral glucose metabolism based on arterial blood samples and image derived measurements and hopefully these will correlate.
Healthy participants will be included, and each participant will participate in one study day, which includes intravenous administration of radioactively labelled glucose (18-FDG), arterial blood sampling and PET scans.
Read the detailed description
Participants will arrive after a four hour fast. An arterial cannulation will be placed in the radial or brachial artery for blood sampling. A venous catheter will be placed in the antecubital vein for administration of 18-FDG. Blood glucose is measured.
Before administration of 18-FDG a "low dose" CT scan of the heart and brain will be performed.
At time 0 minutes 20 MBq 18-FDG will be administered, 10 minutes automatic blood sampling (from the arterial cannulation) will be started and a 10 minutes three part dynamic PET scan of the heart will be performed.
Approximately at time 20 minutes 180 MBq 18-FDG will be administered and a 40 minutes three part dynamic PET scan of the brain will be performed. During the first 10 minutes of the brain scan automatic blood sampling (from the arterial cannulation) will be performed and thereafter manual blood sampling will be performed every 5 minutes.
After the 40 minutes brain PET scan a 5 min post scan of the heart will be performed.
Radioactivity will be measured in the arterial blood samples and the results will be used for an Arterial Input Function (AIF).
Radioactivity measurements derived from the heart scans will be used for an Image Derived Input Function (IDIF).
- Conditions
- Cerebral Glucose Metabolism
- Being tested
- PET with 18-FDG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET with 18-FDGOther
The intervention is a 1,5 hour PET scan, which will be performed in three steps (heart scan, brain scan and heart scan) and administration of radioactively labelled glucose (18-FDG) in two doses.
| Study group | Role | What they receive |
|---|---|---|
| PET with 18-FDG | Experimental | Not described Receives: Other: PET with 18-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax correlation
Difference between the blood-brain glucose transfer capacity (Tmax) calculated based on the image derived input function and Tmax calculated based on the arterial input funcion.
Measured: From administration of 180MBq 18-FDG and during the approximately first 15 min of the brain PET scan
Secondary outcomes (1)
CMRglc correlation
Difference between cerebral metabolic rate of glucose (CMRglc) calculated based on the image derived input function and CMRglc calculated based on the arterial input funcion.
Measured: From administration of 180MBq 18-FDG and during the 40 min brain PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start22 Oct 2024 (estimated)
- Primary completion17 Dec 2024 (estimated)
- Study completion17 Dec 2024 (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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- Lisbeth Marner, MD PhD, Study chair, University Hospital Bispebjerg and FrederiksbergNicolai 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
- NCT06647368
- Sponsor's protocol ID
- GluCoMet_pilotA
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. 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_A
- ClinicalTrials.gov ID
- NCT06647368
- Acronym / sponsor ID
- GluCoMet_pilotA
- Conditions
- Cerebral Glucose Metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Nicolai Jacob Wewer AlbrechtsenUniversity, hospital or other
- Collaborators
- University Hospital Bispebjerg and Frederiksberg
- Study start
- 22 Oct 2024 (estimated)
- Primary completion
- 17 Dec 2024 (estimated)
- Study completion
- 17 Dec 2024 (estimated)
- First posted
- 17 Oct 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.
The aim of the study is to develop a non-invasive method for quantifying cerebral glucose metabolism by PET scans in humans. This method will be used in subsequent studies, where the effect of the pancreatic hormone glucagon on cerebral glucose metabolism will be studied.
The golden standard for quantifying cerebral glucose metabolism by PET scans is based on arterial blood sampling, which complicates research setup. This study will investigate if image derived measurements instead of arterial blood samples can be used to quantify cerebral glucose metabolism.
We will compare the calculations of cerebral glucose metabolism based on arterial blood samples and image derived measurements and hopefully these will correlate.
Healthy participants will be included, and each participant will participate in one study day, which includes intravenous administration of radioactively labelled glucose (18-FDG), arterial blood sampling and PET scans.
Detailed description
Participants will arrive after a four hour fast. An arterial cannulation will be placed in the radial or brachial artery for blood sampling. A venous catheter will be placed in the antecubital vein for administration of 18-FDG. Blood glucose is measured.
Before administration of 18-FDG a "low dose" CT scan of the heart and brain will be performed.
At time 0 minutes 20 MBq 18-FDG will be administered, 10 minutes automatic blood sampling (from the arterial cannulation) will be started and a 10 minutes three part dynamic PET scan of the heart will be performed.
Approximately at time 20 minutes 180 MBq 18-FDG will be administered and a 40 minutes three part dynamic PET scan of the brain will be performed. During the first 10 minutes of the brain scan automatic blood sampling (from the arterial cannulation) will be performed and thereafter manual blood sampling will be performed every 5 minutes.
After the 40 minutes brain PET scan a 5 min post scan of the heart will be performed.
Radioactivity will be measured in the arterial blood samples and the results will be used for an Arterial Input Function (AIF).
Radioactivity measurements derived from the heart scans will be used for an Image Derived Input Function (IDIF).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET with 18-FDG | Experimental | Other: PET with 18-FDG |
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
- Body mass index <= 25 kg/m^2
Key exclusion criteria (14 listed)
- Enrolment in other research project that might interfere with the study
- Diabetes diagnosis
- 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 |
|---|---|---|
| PET with 18-FDGThe intervention is a 1,5 hour PET scan, which will be performed in three steps (heart scan, brain scan and heart scan) and administration of radioactively labelled glucose (18-FDG) in two doses. | Other | PET with 18-FDG |
Primary outcome
Tmax correlation
Time frame: From administration of 180MBq 18-FDG and during the approximately first 15 min of the brain PET scan
Difference between the blood-brain glucose transfer capacity (Tmax) calculated based on the image derived input function and Tmax calculated based on the arterial input funcion.
1 secondary outcome
CMRglc correlation
Time frame: From administration of 180MBq 18-FDG and during the 40 min brain PET scan
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 17 Oct 2024.
Related trials for Cerebral Glucose Metabolism
Active, not recruiting
The Effect of Glucagon on Cerebral Glucose Metabolism in Healthy Humans
Cerebral Glucose Metabolism
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.
Sasha Alexandra S Kjeldsen, MSc PhD contact
Lisbeth Marner, MD PhD study chair
University Hospital Bispebjerg and Frederiksberg
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 PET with 18-FDG 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: looking for participants now, as of the sponsor's last update on 17 Oct 2024. 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 Nina L Hansen, MD (004521205944, nina.lerberg.hansen.01@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax correlation (time frame: From administration of 180MBq 18-FDG and during the approximately first 15 min of the brain PET scan). 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 17 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.