Glucose MetabolismNCT07366710
Measuring Amino Acid and Glucose Metabolism in Healthy Volunteers and NAFLD Patients Using Total-body PET
A study testing 18F-FDG (oral), 18F-FDG (intravenous) and 18F-FET (oral) in people with Glucose Metabolism and NAFLD (Nonalcoholic Fatty Liver Disease), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This observational study aims to quantify whole-body amino acid and glucose metabolism in healthy adults and in patients with non-alcoholic fatty liver disease (NAFLD) using total-body PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glucose Metabolism, NAFLD (Nonalcoholic Fatty Liver Disease)
- What is being tested?
- 18F-FDG (oral), 18F-FDG (intravenous) and 18F-FET (oral)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Nov 2024to Oct 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- Body mass index (BMI) 20-27 kg/m2
Who cannot join
- Pregnancy
- Claustrophobia
- Inability to give consent due to psychological or other causes
- Inability to speak/read Danish
- Diabetes, cancer (active or treated within the last five years) or inflammatory diseases.
- Low albumin
- Chronic disorders that require medical treatment
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100
About this study
Official title: Quantification of Amino Acid and Glucose Metabolism in Healthy Controls and Patients With Non-alcoholic Fatty Liver Disease Using Total- Body PET
This observational study aims to quantify whole-body amino acid and glucose metabolism in healthy adults and in patients with non-alcoholic fatty liver disease (NAFLD) using total-body PET/CT. The study investigates how orally and intravenously administered PET tracers (18F-FDG and 18F-FET) are absorbed in the gastrointestinal tract, distributed across major organs, and metabolized in different physiological and pathological states. A further objective is to examine how glucagon, during a pancreatic clamp using somatostatin, influences amino acid metabolism in healthy individuals and whether this response is altered in patients with NAFLD.
Participants will be healthy volunteers or patients with NAFLD, aged 18-70 years. Depending on study group, participants will undergo one or more total-body PET/CT scans following oral or intravenous tracer administration, and in some cases receive glucagon or placebo infusion. Blood samples will be collected during scanning to assess hormone levels and metabolic responses. Data from these imaging sessions will be used to characterize nutrient metabolism, compare oral and intravenous tracer kinetics, and explore glucagon-induced metabolic changes across study groups.
- Being tested
- 18F-FDG (oral), 18F-FDG (intravenous), 18F-FET (oral), 18F-FET (intravenous), Glucagon
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG (oral)Drug
Oral administration of 18F-fluorodeoxyglucose (^18F-FDG) for total-body PET/CT to assess gastrointestinal absorption, systemic biodistribution, and whole-body glucose metabolism.
18F-FDG (intravenous)Drug
Intravenous bolus administration of 18F-fluorodeoxyglucose (18F-FDG) for total-body PET/CT to measure systemic biodistribution and whole-body glucose metabolism.
18F-FET (oral)Drug
Oral administration of O-(2-[18F]fluoroethyl)-L-tyrosine (18F-FET) for total-body PET/CT to assess gastrointestinal amino acid absorption and whole-body amino acid metabolism.
18F-FET (intravenous)Drug
Intravenous bolus administration of O-(2-[18F]fluoroethyl)-L-tyrosine (18F-FET) for total-body PET/CT to measure systemic amino acid biodistribution and dynamic metabolic kinetics.
GlucagonDrug
Continuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp.
SomatostatinDrug
Continuous intravenous somatostatin infusion to suppress endogenous pancreatic hormone secretion during the pancreatic clamp.
Sodium chloride (placebo)Drug
Intravenous infusion of isotonic sodium chloride solution used as placebo during crossover comparison with glucagon infusion.
Oral Glucose Tolerance TestOther
Standard oral glucose load (75 g in 250 mL water) to assess glucose-stimulated metabolic responses during PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls: FDG (oral & IV) | Experimental | Healthy volunteers receive 18F-FDG by oral administration and intravenous administration on separate study days, including an oral glucose tolerance test visit. Total-body PET/CT imaging is performed after each tracer administration. Receives: Drug: 18F-FDG (oral); Drug: 18F-FDG (intravenous); Other: Oral Glucose Tolerance Test |
| Healthy Controls: FET (oral & IV) | Experimental | Healthy volunteers receive 18F-FET by oral administration and intravenous administration on separate study days. Dynamic and static total-body PET/CT imaging is performed. Receives: Drug: 18F-FET (oral); Drug: 18F-FET (intravenous) |
| Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover) | Experimental | Healthy participants undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design. Receives: Drug: 18F-FET (oral); Drug: Glucagon; Drug: Somatostatin; Drug: Sodium chloride (placebo) |
| NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) | Experimental | Participants with NAFLD undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design. Receives: Drug: 18F-FET (oral); Drug: Glucagon; Drug: Somatostatin; Drug: Sodium chloride (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT
Measured: 0-180 minutes after tracer administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start5 Nov 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 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.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Cramon, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366710
- Sponsor's protocol ID
- 565_23
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Amino Acid and Glucose Metabolism in Healthy Controls and Patients With Non-alcoholic Fatty Liver Disease Using Total- Body PET
- ClinicalTrials.gov ID
- NCT07366710
- Acronym / sponsor ID
- 565_23
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 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.
This observational study aims to quantify whole-body amino acid and glucose metabolism in healthy adults and in patients with non-alcoholic fatty liver disease (NAFLD) using total-body PET/CT. The study investigates how orally and intravenously administered PET tracers (18F-FDG and 18F-FET) are absorbed in the gastrointestinal tract, distributed across major organs, and metabolized in different physiological and pathological states. A further objective is to examine how glucagon, during a pancreatic clamp using somatostatin, influences amino acid metabolism in healthy individuals and whether this response is altered in patients with NAFLD.
Participants will be healthy volunteers or patients with NAFLD, aged 18-70 years. Depending on study group, participants will undergo one or more total-body PET/CT scans following oral or intravenous tracer administration, and in some cases receive glucagon or placebo infusion. Blood samples will be collected during scanning to assess hormone levels and metabolic responses. Data from these imaging sessions will be used to characterize nutrient metabolism, compare oral and intravenous tracer kinetics, and explore glucagon-induced metabolic changes across study groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls: FDG (oral & IV) | Experimental | Drug: 18F-FDG (oral), Drug: 18F-FDG (intravenous), Other: Oral Glucose Tolerance TestHealthy volunteers receive 18F-FDG by oral administration and intravenous administration on separate study days, including an oral glucose tolerance test visit. Total-body PET/CT imaging is performed after each tracer administration. |
| Healthy Controls: FET (oral & IV) | Experimental | Drug: 18F-FET (oral), Drug: 18F-FET (intravenous)Healthy volunteers receive 18F-FET by oral administration and intravenous administration on separate study days. Dynamic and static total-body PET/CT imaging is performed. |
| Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover) | Experimental | Drug: 18F-FET (oral), Drug: Glucagon, Drug: Somatostatin, Drug: Sodium chloride (placebo)Healthy participants undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design. |
| NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) | Experimental | Drug: 18F-FET (oral), Drug: Glucagon, Drug: Somatostatin, Drug: Sodium chloride (placebo)Participants with NAFLD undergo two study days with oral ^18F-FET administration combined with either glucagon infusion during a pancreatic clamp (somatostatin infusion) or placebo. Total-body PET/CT imaging is performed using a crossover design. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-70 years
- Body mass index (BMI) 20-27 kg/m2
Key exclusion criteria (7 listed)
- Pregnancy
- Claustrophobia
- Inability to give consent due to psychological or other causes
- Inability to speak/read Danish
- Diabetes, cancer (active or treated within the last five years) or inflammatory diseases.
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 |
|---|---|---|
| 18F-FDG (oral)Oral administration of 18F-fluorodeoxyglucose (^18F-FDG) for total-body PET/CT to assess gastrointestinal absorption, systemic biodistribution, and whole-body glucose metabolism. | Drug | Healthy Controls: FDG (oral & IV) |
| 18F-FDG (intravenous)Intravenous bolus administration of 18F-fluorodeoxyglucose (18F-FDG) for total-body PET/CT to measure systemic biodistribution and whole-body glucose metabolism. | Drug | Healthy Controls: FDG (oral & IV) |
| 18F-FET (oral)Oral administration of O-(2-[18F]fluoroethyl)-L-tyrosine (18F-FET) for total-body PET/CT to assess gastrointestinal amino acid absorption and whole-body amino acid metabolism. | Drug | Healthy Controls: FET (oral & IV), Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover), NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) |
| 18F-FET (intravenous)Intravenous bolus administration of O-(2-[18F]fluoroethyl)-L-tyrosine (18F-FET) for total-body PET/CT to measure systemic amino acid biodistribution and dynamic metabolic kinetics. | Drug | Healthy Controls: FET (oral & IV) |
| GlucagonContinuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp. | Drug | Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover), NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) |
| SomatostatinContinuous intravenous somatostatin infusion to suppress endogenous pancreatic hormone secretion during the pancreatic clamp. | Drug | Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover), NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) |
| Sodium chloride (placebo)Intravenous infusion of isotonic sodium chloride solution used as placebo during crossover comparison with glucagon infusion. | Drug | Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover), NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) |
| Oral Glucose Tolerance TestStandard oral glucose load (75 g in 250 mL water) to assess glucose-stimulated metabolic responses during PET/CT. | Other | Healthy Controls: FDG (oral & IV) |
Primary outcome
Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT
Time frame: 0-180 minutes after tracer administration
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 2 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FDG (oral), 18F-FDG (intravenous) and 18F-FET (oral) in people with Glucose Metabolism and NAFLD (Nonalcoholic Fatty Liver Disease), run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 7 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 2 Feb 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?
Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT (time frame: 0-180 minutes after tracer administration). 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 2 Feb 2026.