Human Models of Selective Insulin Resistance: Pancreatic Clamp

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): one (experimental) and one (experimental).

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

More on the Plan

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

In order to answer this question, the investigators will recruit people with MASLD at risk for T2DM 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.

Who Took Part

36 planned participants were the target.

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: Men and women, ages 18-65 years. Body mass index of 27-50 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:. Homeostasis Model of Insulin Resistance (HOMA-IR) score ≥ 2.73.

The full record lists 11 inclusion and 73 exclusion criteria; among the exclusions: unable to provide informed consent in english or spanish; unwillingness to use only bedpan or urinal to void or to refrain from non-emergent mobile device use during the clamp; abnormal blood pressure (including on treatment, if prescribed).

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2027-01-01 with completion listed for 2028-12-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Endogenous glucose production (EGP) (absolute value) (time frame: Up to 6.5 hours of pancreatic clamp protocol). Endogenous glucose production (EGP) (relative value) (time frame: Up to 6.5 hours of pancreatic clamp protocol). Plasma glucose level (time frame: Up to 6.5 hours of pancreatic clamp protocol).

It also tracked 6 secondary outcomes, for example Serum or plasma triglyceride level, Plasma free fatty acids level, Glucose kinetics: rate of appearance (absolute value), Glucose kinetics: rate of appearance (relative value), Glucose kinetics: rate of disappearance (absolute value) and Glucose kinetics: rate of disappearance (relative value).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) and Glucagon 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 not yet recruiting; 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.