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Could oxidative stress be the hidden culprit behind blood vessel damage after gestational diabetes?

NCT ID NCT05946785

Knowledge-focused Sponsor: Anna Stanhewicz, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This early-phase trial investigates whether oxidative stress—an imbalance of damaging free radicals and protective antioxidants—causes small blood vessel dysfunction in otherwise healthy women who previously had gestational diabetes. Researchers will deliver two drugs (acetylcholine and insulin aspart) through tiny fibers placed in the skin to measure how blood vessels respond, with and without an antioxidant. The goal is to understand the underlying mechanism, not to test a new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acetylcholine and insulin aspart perfused through microdialysis fibers in the skin
What this could lead to
If oxidative stress is confirmed as a key driver, this could point toward antioxidant-based strategies to protect blood vessel health after gestational diabetes.
What could go wrong
This is a very small, early-phase mechanistic study in healthy volunteers with a history of gestational diabetes. Results may not translate to real-world treatments or apply to broader populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

INCLUSION CRITERIA: * female sex * 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 EXCLUSION CRITERIA: * skin diseases * current tobacco/e-cigarette use * diagnosed or suspected hepatic or metabolic disease including diabetes * statin or other cholesterol-lowering medication * current antihypertensive medication * history of preeclampsia or gestational hypertension * current pregnancy * body mass index \<18.5 kg/m2 * allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs.

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Conditions

The condition(s) this trial relates to.

gestational diabetes

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes Vascular endothelial function

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

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