Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

What Was Tested

This registered early phase 1 trial tested Insulin Aspart.

The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.

It had four arms (groups): local lactated Ringer's perfusion (placebo comparator), local apocynin perfusion (experimental), local L-NAME perfusion (experimental) and local apocynin + L-NAME perfusion (experimental).

Lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control.

Local apocynin is perfused through the microdialysis fiber to serve as the NADPH oxidase inhibited experimental treatment.

Local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase.

The registry classes the interventions as drug.

More on the Plan

Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy.

While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans.

As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure NADPH oxidase expression and markers of oxidative stress in these cells.

Who Took Part

40 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: 18 years or older. Pregnant within 5 years of the study visit. Had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes. Or without a history of gestational diabetes.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: skin diseases; current tobacco or electronic cigarette/vape pen use,; diagnosed or suspected hepatic or metabolic disease including diabetes,.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin Aspart study did not mask who received what.

It started in 2023-08-30 with completion listed for 2026-06-30.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: microvascular acetylcholine-mediated dilation (time frame: at the study visit, an average of 4 hours). microvascular insulin-mediated dilation (time frame: at the study visit, an average of 4 hours).

It also tracked 1 secondary outcome, for example endothelial cell NADPH oxidase expression.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Insulin Aspart in 40 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.