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

Rigshospitalet

Status: Active, not recruiting

Conditions: NAFLD (Nonalcoholic Fatty Liver Disease); Glucose Metabolism

Treatments: Drug: Sodium chloride (placebo); Drug: 18F-FET (intravenous); Drug: Glucagon; Drug: 18F-FDG (oral); Drug: 18F-FDG (intravenous); Other: Oral Glucose Tolerance Test; Drug: Somatostatin; Drug: 18F-FET (oral)

Study type: Interventional

Funder types: Other

Identifiers

NCT07366710

565_23

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

36 participants in 4 patient groups

Healthy Controls: FDG (oral & IV)

Experimental group

Description:

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.

Treatment:

Other: Oral Glucose Tolerance Test

Drug: 18F-FDG (intravenous)

Drug: 18F-FDG (oral)

Healthy Controls: FET (oral & IV)

Experimental group

Description:

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.

Treatment:

Drug: 18F-FET (oral)

Drug: 18F-FET (intravenous)

Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover)

Experimental group

Description:

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.

Treatment:

Drug: Somatostatin

Drug: 18F-FET (oral)

Drug: Glucagon

Drug: Sodium chloride (placebo)

NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover)

Experimental group

Description:

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.

Treatment:

Drug: Somatostatin

Drug: 18F-FET (oral)

Drug: Glucagon

Drug: Sodium chloride (placebo)