Recruiting
Early Phase 1

Observational Study

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT05946785

Conditions

Gestational Diabetes

Vascular Endothelial Function

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Acetylcholine

insulin aspart

Study Details

Brief summary:

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.

Conditions

Gestational Diabetes

Vascular Endothelial Function

Study ID

NCT05946785

Start date

Jul 1, 2023

Status verified date

Jul, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: local lactated Ringer's perfusion

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

experimental: local ascorbate perfusion

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

experimental: local L-NAME perfusion

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

Interventions

Acetylcholine

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

insulin aspart

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

Primary outcome 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 ]

Central Contacts and Locations

Central contacts

Anna Reid-Stanhewicz, PHD

319-467-1732anna-stanhewicz@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Anna Stanhewicz, PhD

319-467-1732anna-stanhewicz@uiowa.edu

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • gestational diabetes
  • postpartum
  • vascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2026-07-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.