Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity

What Was Tested

In this phase 4 trial, researchers set out to test Insulin (regular human).

The goal of this study is to quantify day-to-day changes in blood glucose during treatment towards remission in ketosis-prone diabetes (KPDM) and describe them using a mathematical model of KPDM pathogenesis and remission.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as device and drug.

More on the Plan

Approximately half of newly diagnosed obese African Americans presenting with diabetic ketoacidosis (DKA) have clinical, metabolic and immunologic features of type 2 diabetes (T2D), also known as ketosis-prone diabetes (KPDM).

The clinical course of KPDM is variable, with the duration of remission ranging from 6 to 120 months.

The origins of this variation in the ability to achieve remission and its duration are poorly understood.

The researchers thus hypothesized that the differences between conventional T2D and KPDM may be explained by the presence of a reversible glucotoxicity process, which operates on the timescale of days.

Who Took Part

Enrollment: 12 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Provide informed consent. Have a BMI ≥ 28 kg/m2. Be of African American ancestry.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: have recognized uncontrolled endocrine disorders such as hypercortisolism, acromegaly, or hyperthyroidism; diagnosis of diabetes \> 90 days before the presentation of dka; unable to give consent.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-01-23 with completion listed for 2027-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Quantify Changes in Blood Glucose (time frame: Up to 3 months). Development of Mathematical Models (time frame: Up to 3 months).

It also tracked 1 secondary outcome, for example Correlation of Fit With Model Parameters and Duration of Remission.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin (regular human) in 12 people.

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

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, all human trials.