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NCT Number: NCT07366710

Measuring Amino Acid and Glucose Metabolism in Healthy Volunteers and NAFLD Patients 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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital - Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT

    Time frame: 0-180 minutes after tracer administration

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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