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Clinical Trial NCT07366710 for Glucose Metabolism, NAFLD (Nonalcoholic Fatty Liver Disease) is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Measuring Amino Acid and Glucose Metabolism in Healthy Volunteers and NAFLD Patients Using Total-body PET 36 Observational
Clinical Trial NCT07366710 is an interventional study for Glucose Metabolism, NAFLD (Nonalcoholic Fatty Liver Disease) that is active, not recruiting. It started on November 5, 2024 with plans to enroll 36 participants. Led by Rigshospitalet, Denmark, it is expected to complete by October 1, 2027. The latest data from ClinicalTrials.gov was last updated on February 2, 2026.
Brief 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 path...Show More
Official Title
Quantification of Amino Acid and Glucose Metabolism in Healthy Controls and Patients With Non-alcoholic Fatty Liver Disease Using Total- Body PET
Conditions
Glucose MetabolismNAFLD (Nonalcoholic Fatty Liver Disease)Other Study IDs
- 565_23
NCT ID Number
Start Date (Actual)
2024-11-05
Last Update Posted
2026-02-02
Completion Date (Estimated)
2027-10
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Primary Purpose
Basic Science
Design Allocation
Non-Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalHealthy Controls: FDG (oral & IV) 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. | 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. 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. Oral Glucose Tolerance Test Standard oral glucose load (75 g in 250 mL water) to assess glucose-stimulated metabolic responses during PET/CT. |
ExperimentalHealthy Controls: FET (oral & IV) 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. | 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. 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. |
ExperimentalHealthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover) 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. | 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. Glucagon Continuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp. Somatostatin Continuous intravenous somatostatin infusion to suppress endogenous pancreatic hormone secretion during the pancreatic clamp. Sodium chloride (placebo) Intravenous infusion of isotonic sodium chloride solution used as placebo during crossover comparison with glucagon infusion. |
ExperimentalNAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) 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-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. Glucagon Continuous intravenous glucagon infusion to stimulate hepatic amino acid metabolism during a pancreatic clamp. Somatostatin Continuous intravenous somatostatin infusion to suppress endogenous pancreatic hormone secretion during the pancreatic clamp. Sodium chloride (placebo) Intravenous infusion of isotonic sodium chloride solution used as placebo during crossover comparison with glucagon infusion. |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT | 0-180 minutes after tracer administration |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Age 18-70 years
- Body mass index (BMI) 20-27 kg/m2
- 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
Rigshospitalet, DenmarkStudy Responsible Party
Per Cramon, Principal Investigator, Physician, Rigshospitalet, Denmark
No contact data.
1 Study Locations in 1 Countries
Copenhagen University Hospital - Rigshospitalet, Copenhagen, 2100, Denmark