Measuring Amino Acid and Glucose Metabolism in Healthy Volunteers and NAFLD Patients Using Total-body PET

NCT07366710 — Not applicable, Active not recruiting, 36 participants, Copenhagen University Hospital, Rigshospitalet

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Quantification of Amino Acid and Glucose Metabolism in Healthy Controls and Patients With Non-alcoholic Fatty Liver Disease Using Total- Body PET

Registry	NCT07366710
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: none, basic science
Enrollment	36 (Estimated)
Sponsor	Copenhagen University Hospital, Rigshospitalet (Other)
Conditions	Glucose Metabolism, NAFLD (Nonalcoholic Fatty Liver Disease)
Interventions	18F-FDG (oral), 18F-FDG (intravenous), 18F-FET (oral), 18F-FET (intravenous), Glucagon, Somatostatin, Sodium chloride (placebo), Oral Glucose Tolerance Test (Drug, other)
Dates	start 2024-11-05, primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-01-26, last updated 2026-02-02
Locations	1 site in Denmark

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Healthy Controls: FDG (oral & IV)	Experimental	Drug: 18F-FDG (oral); Drug: 18F-FDG (intravenous); Other: Oral Glucose Tolerance Test	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.
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.

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.
Glucagon (Drug): Continuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp.
Somatostatin (Drug): 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 Test (Other): Standard oral glucose load (75 g in 250 mL water) to assess glucose-stimulated metabolic responses during PET/CT.

+Outcome measures

Primary outcomes

Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT [0-180 minutes after tracer administration]

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Age 18-70 years
* Body mass index (BMI) 20-27 kg/m2

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Copenhagen University Hospital - Rigshospitalet	Copenhagen	Denmark