Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

What Was Tested

This registered early phase 1 trial tested Insulin Aspart.

The purpose of this investigation is to examine the role of oxidative stress in aberrant microvascular function in otherwise healthy women with a history of GDM.

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

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

Local ascorbate is perfused through the microdialysis fiber to serve as the antioxidant 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.

The purpose of this investigation is to examine the role of oxidative stress in mediating vascular dysfunction in women who have had gestational diabetes.

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.

Who Took Part

The registry lists 28 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 -50 years old. Pregnancy history 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 5 inclusion and 9 exclusion criteria; among the exclusions: skin diseases; current tobacco/e-cigarette 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.

Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.

It started in 2023-07-01 with completion listed for 2026-12-31.

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 2 secondary outcomes, for example endothelial cell markers of oxidative stress and endothelial cell insulin-stimulated eNOS phosphorylation.

What This Means in Plain Language

Put simply, this is a early phase 1, non-randomized trial of Insulin Aspart in 28 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 Aspart compound page, all human trials.