Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance

What Was Tested

The trial (phase 4) is built around Insulin (regular human) for insulin resistance, prediabetes & type 2 diabetes.

The purpose of this study is to examine the impact of timed cortisol release or differently timed cortisol rhythms on insulin resistance in both men and women undergoing sleep restriction.

Chronic sleep loss is highly prevalent, affecting 1 in 3 adults in the US.

Chronic sleep loss causes stress which induces insulin resistance and leads to obesity and type 2 diabetes.

It had four arms (groups): Misaligned cortisol rhythm-night shift condition (active comparator), Realigned cortisol rhythm-night shift condition (active comparator), Fixed cortisol shape condition- day shift condition (active comparator) and Unfixed cortisol shape condition-day shift condition (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Sleep loss causes stress, induces insulin resistance (IR) and leads to obesity and type 2 diabetes mellitus (T2D).

Sleep loss is highly prevalent, affecting 1 in 3 adults in the USA.

This finding unequivocally identifies cortisol and testosterone signaling to be major pathways by which sleep loss imbalances metabolic processes and triggers IR - a critical pathogenic factor for T2D.

These hormonal pathways are now prime candidates for developing mechanistically informed methods to avert IR and its devastating consequences, because no other putative pathway has been verified experimentally in humans.

Who Took Part

48 planned participants were the target.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Must be between 18-45 years old. Has a BMI of 18-25 kg/m2 stable weight over the previous 6 weeks. No history of clinically relevant psychiatric illness. No previous history of drug or alcohol abuse. Not a current smoker.

The full record lists 20 inclusion and 0 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Neither the insulin resistance, prediabetes & type 2 diabetes participants nor the staff measuring them knew who was on Insulin (regular human), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2026-07-16 with completion listed for 2029-03.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Insulin resistance-Minimal Model (Si) (time frame: Change from baseline collection). Insulin Resistance-Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) (time frame: Change from baseline collection). Insulin Resistance-Insulin Sensitivity Index (Mi) (time frame: Change from baseline collection).

It also tracked 4 secondary outcomes, for example Psychomotor Vigilance Test (PVT) Lapses, Metabolomics, Karolinska Sleepiness Scale (KSS) Scores and Delta-4 steroid hormones.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 48 people with insulin resistance, prediabetes & type 2 diabetes.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Insulin resistance, prediabetes & type 2 diabetes research.