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

What Was Tested

The trial (not phased) is built around Glucagon and Somatostatin for fatty liver & elevated liver enzymes.

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.

It had four arms (groups): Healthy Controls: FDG (oral & IV) (experimental), Healthy Controls: FET (oral & IV) (experimental), Healthy Controls: Oral FET + Glucagon/Somatostatin Clamp (Crossover) (experimental) and NAFLD Patients: Oral FET + Glucagon/Somatostatin Clamp (Crossover) (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.

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.

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.

The registry classes the interventions as drug and other.

Who Took Part

36 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-70 years. Body mass index (BMI) 20-27 kg/m2.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: non-randomized, crossover and open-label.

In the crossover set-up each of the fatty liver & elevated liver enzymes participants took both Glucagon and the comparison in turn, acting as their own control.

Everyone knew when Glucagon was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-11-05 with completion listed for 2027-10.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Whole-body tracer uptake (SUVmean) assessed using total-body PET/CT (time frame: 0-180 minutes after tracer administration).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Glucagon and Somatostatin in 36 people with fatty liver & elevated liver enzymes.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glucagon compound page and the Somatostatin compound page, Fatty liver & elevated liver enzymes research.