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ACTIVE NOT RECRUITING
NCT07366710
NA

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

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-11-05

Completion Date

2027-10

Last Updated

2026-02-02

Healthy Volunteers

No

Interventions

DRUG

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

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

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

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

Glucagon

Continuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp.

DRUG

Somatostatin

Continuous intravenous somatostatin infusion to suppress endogenous pancreatic hormone secretion during the pancreatic clamp.

DRUG

Sodium chloride (placebo)

Intravenous infusion of isotonic sodium chloride solution used as placebo during crossover comparison with glucagon infusion.

OTHER

Oral Glucose Tolerance Test

Standard oral glucose load (75 g in 250 mL water) to assess glucose-stimulated metabolic responses during PET/CT.

Locations (1)

Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark