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Taking people in United StatesEarly phase 1

Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

Key facts

Who runs it
Anna Stanhewicz, PhD
Where
Iowa City, United StatesSee the site
Trial code
Status
Recruiting
Phase
Early phase 1
People taking part
28 people, planned
Started
1 Jul 2023
Expected to end
1 Jun 2027
Type of study
Interventional, 3 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Acetylcholine
  • insulin aspart
Record updated
29 July 2026

Who can take part

Age
18 years to 50 years
Sex
Women only
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 50 years old?

Where in United States

  • University of IowaIowa City, United StatesContact: Anna Stanhewicz, PhDTaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • local lactated Ringer's perfusionPlacebo, for comparison

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

    Treatment: Acetylcholine and insulin aspart

  • local ascorbate perfusionTreatment being tested

    local ascorbate is perfused through the microdialysis fiber to serve as the antioxidant experimental treatment

    Treatment: Acetylcholine and insulin aspart

  • local L-NAME perfusionTreatment being tested

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

    Treatment: Acetylcholine and insulin aspart

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Role of Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes
Fit questions
Built from NCT05946785, who can take part
Record updated
29 July 2026