Dexamethasone/Pancreatic Clamp P&F

What Was Tested

In this phase 1 trial, researchers set out to test Insulin (regular human) and Glucagon for fatty liver & elevated liver enzymes and insulin resistance, prediabetes & type 2 diabetes.

It had two arms (groups): Maintenance hyperinsulinemia (MH) protocol (active comparator) and one (experimental).

The registry classes the interventions as device, dietary supplement, drug and other.

More on the Plan

Unchecked, NAFLD can progress to severe liver inflammation, liver failure, and even liver cancer.

They will then perform a "pancreatic clamp" - a procedure in which the body's production of insulin is temporarily shut off and then replaced at the same or lower levels.

Again, the investigators expect that lowering insulin levels will lower fat production.

Because this is a new research approach, the investigators first need to understand how lowering insulin levels affects blood sugar.

Who Took Part

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Body mass index of 25.0-39.9 kg/m2. Able to understand written and spoken English and/or Spanish. Normal fasting serum insulin (fasting insulin level \< 12 μIU/mL) on screening labs.

The full record lists 6 inclusion and 89 exclusion criteria; among the exclusions: unable to provide informed consent in english or spanish; concerns arising at screening visit (any of the following):; systolic blood pressure \< 90 mm hg or \> 160 mm hg, and/or.

How the Study Was Run

It was run as a randomized, crossover and single-blind study.

The fatty liver & elevated liver enzymes participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2024-07-01 with completion listed for 2025-11-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Absolute values of plasma glucose (time frame: Up to 425 minutes from the start of the procedure). Relative change in plasma glucose (time frame: Up to 425 minutes from the start of the procedure). Absolute values of serum insulin (time frame: Up to 425 minutes from the start of the procedure).

It also tracked 9 secondary outcomes, for example Absolute values of serum or plasma triglyceride (TG), Relative change in absolute values of serum or plasma triglyceride (TG), Absolute values of serum or plasma free fatty acid (FFA), Relative change in serum or plasma free fatty acid (FFA), Absolute values of serum or plasma apolipoprotein B (ApoB) and Relative change in serum or plasma apolipoprotein B (ApoB).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Glucagon in people with fatty liver & elevated liver enzymes.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Glucagon compound page, Fatty liver & elevated liver enzymes research, Insulin resistance, prediabetes & type 2 diabetes research.