Pancreatic Clamp in NAFLD

What Was Tested

The trial (phase 1) is built around 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.

In order to answer this question, the investigators will recruit people at risk for T2DM and NAFLD to 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

18 actual participants 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 25-45 kg/m2. Able to understand written and spoken English and/or Spanish. Evidence of insulin resistance, represented by any or all of the following criteria:. Fasting hyperinsulinemia (fasting insulin level ≥ 13 µIU/mL) on screening labs.

The full record lists 7 inclusion and 38 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

The set-up was randomized, crossover and single-blind.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

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 2023-08-29 with completion listed for 2025-09-24.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Plasma glucose (absolute values) (units: mg/dL) (time frame: Up to 425 minutes from the start of the procedure). Plasma glucose (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points) (time frame: Up to 425 minutes from the start of the procedure). Serum insulin (relative/change) (units: fold difference and/or ∆ µIU/mL relative to previous time points) (time frame: Up to 425 minutes from the start of the procedure).

It also tracked 9 secondary outcomes, for example Serum or plasma triglyceride (TG) (absolute values) (units: mg/dL), Serum or plasma triglyceride (TG) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points), Serum or plasma free fatty acid (FFA) (absolute values) (units: mg/dL), Serum or plasma free fatty acid (FFA) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points), Serum or plasma apolipoprotein B (ApoB) (absolute values) (units: mg/dL) and Serum or plasma apolipoprotein B (ApoB) (relative/change) (units: fold difference and/or ∆mg/dL relative to previous time points).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Glucagon in 18 people with fatty liver & elevated liver enzymes.

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

The trial is marked completed; 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.