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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT | 0-180 minutes after tracer administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - Rigshospitalet | Copenhagen | 2100 | Denmark |
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| 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. |
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| Glucagon | Drug | Continuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp. |
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| Somatostatin | Drug | Continuous intravenous somatostatin infusion to suppress endogenous pancreatic hormone secretion during the pancreatic clamp. |
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| Sodium chloride (placebo) | Drug | Intravenous infusion of isotonic sodium chloride solution used as placebo during crossover comparison with glucagon infusion. |
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| Oral Glucose Tolerance Test | Other | Standard oral glucose load (75 g in 250 mL water) to assess glucose-stimulated metabolic responses during PET/CT. |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| C545932 | (18F)fluoroethyltyrosine |
| D005934 | Glucagon |
| D013004 | Somatostatin |
| D012965 | Sodium Chloride |
| D005951 | Glucose Tolerance Test |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008919 | Investigative Techniques |
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