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NCT Number: NCT05946785

Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Anna Stanhewicz, PhD

CONTACT

[email protected]

319-467-1732

About this study

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. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

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. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure markers of oxidative stress and insulin-mediated eNOS phosphorylation in these cells.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetylcholine

Drug

acetylcholine is perfused at 10 ascending concentrations (10^-10M - 10^-1 M) for 5 minutes each

insulin aspart

Drug

insulin aspart is perfused at 5 ascending concentrations (10^-8M - 10^-4 M) for 10 minutes each

Primary outcomes

  1. microvascular acetylcholine-mediated dilation

    Time frame: at the study visit, an average of 4 hours

    cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, ascorbate, and L-NAME treated microdialysis sites

  2. microvascular insulin-mediated dilation

    Time frame: at the study visit, an average of 4 hours

    cutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, ascorbate, and L-NAME treated microdialysis sites

Secondary outcomes

  1. endothelial cell markers of oxidative stress

    Time frame: at the study visit, an average of 4 hours

    nitrotyrosine, MnSOD and NADPH oxidase expression in biopsied endothelial cells

  2. endothelial cell insulin-stimulated eNOS phosphorylation

    Time frame: at the study visit, an average of 4 hours

    eNOS phosphorylation response to incubation with insulin in biopsied endothelial cells

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Reid-Stanhewicz, PHD

CONTACT

[email protected]

319-467-1732

Sponsors and collaborators

Lead sponsor

Anna Stanhewicz, PhD

Other

Registry information

Official study title

Role of Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 14, 2023
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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