Copenhagen University Hospital - Rigshospitalet
Copenhagen, 2100, Denmark
NCT Number: NCT07366710
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral administration of 18F-fluorodeoxyglucose (^18F-FDG) for total-body PET/CT to assess gastrointestinal absorption, systemic biodistribution, and whole-body glucose metabolism.
Intravenous bolus administration of 18F-fluorodeoxyglucose (18F-FDG) for total-body PET/CT to measure systemic biodistribution and whole-body glucose metabolism.
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.
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.
Continuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp.
Continuous intravenous somatostatin infusion to suppress endogenous pancreatic hormone secretion during the pancreatic clamp.
Intravenous infusion of isotonic sodium chloride solution used as placebo during crossover comparison with glucagon infusion.
Standard oral glucose load (75 g in 250 mL water) to assess glucose-stimulated metabolic responses during PET/CT.
Time frame: 0-180 minutes after tracer administration
Rigshospitalet, Denmark
Other
Quantification of Amino Acid and Glucose Metabolism in Healthy Controls and Patients With Non-alcoholic Fatty Liver Disease Using Total- Body PET
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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