Recruiting
Phase 1

Gestational Diabetes

Sponsor:

Anna Stanhewicz, PhD

Code:

NCT06911372

Conditions

Gestational Diabetes Mellitus (GDM)

Postpartum Women

Uncomplicated Pregnancy

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Intradermal Microdialysis

Brain Blood Flow Tests

Local Heating

Study Details

Brief summary:

Gestational Diabetes Mellitus (GDM) currently affects approximately 14% of all pregnancies worldwide. Importantly, the health-related consequences of GDM extend well beyond pregnancy, such that women with a history of GDM have a 40% increased risk of cerebrovascular diseases and a 67% increased risk of dementia, compared to women with a history of uncomplicated pregnancy. Women with a history of GDM have impaired skin microvascular function, compared with women with a history of uncomplicated pregnancy. Therefore, it's likely that GDM results in impaired brain blood vessel function, yet there is little-to-no information regarding the effects of GDM on brain blood vessel health and function after pregnancy.

Therefore, the purpose of the study is to evaluate the effects of GDM on brain blood flow and brain blood vessel function in healthy women with either a history of GDM or uncomplicated pregnancy.

In this study, the investigators will use two different types of ultrasound to non-invasively measure brain blood flow. Brain blood vessel function will be evaluated by examining the brain blood flow responses to increases in carbon dioxide (the increases in carbon dioxide are similar to what is experienced during a breath hold). Additionally, the investigators will compare the brain blood flow results to skin microvascular function to explore potential mechanisms behind possible impairments in brain blood vessel function. Skin microvascular function will be assessed using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) on dime sized areas of the forearm. Finally, for screening purposes and to further explore potential mechanisms behind any potential impairments in brain blood vessel function, the investigators will perform blood draws to determine the metabolic health of the participants and to analyze for substances that influence blood vessel function.

Conditions

Gestational Diabetes Mellitus (GDM)

Postpartum Women

Uncomplicated Pregnancy

Study ID

NCT06911372

Start date

Aug 22, 2025

Status verified date

Dec, 2025

Completion date

Apr 15, 2028

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

INCLUSION CRITERIA:

  • Post-partum women
  • 18 years or older
  • Delivered within 5 years from the study visit
  • History of gestational diabetes diagnosed by an obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes OR history of uncomplicated pregnancy (defined as no history of gestational diabetes, hypertensive pregnancy, or other gestational disorder).

EXCLUSION CRITERIA: We exclude participants from both groups for:

  • Skin diseases
  • Current tobacco use
  • Diagnosed or suspected hepatic or metabolic disease including diabetes
  • Diagnosed with depression or other mood-related disorders, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or pulmonary fibrosis
  • Use of prescribed NSAIDs, statins or other cholesterol-lowering medication, antihypertensive medication, carbonic anhydrase inhibitors, corticosteroids, thyroid medications, antidepressants or mood stabilizers, diuretics, phenothiazines, or benzodiazepines
  • History of preeclampsia or gestational hypertension,
  • History or family history of panic disorder,
  • Currently pregnant
  • Body mass index <18.5 kg/m2,
  • Allergy to materials used during the experiment (e.g. latex), known allergies to study drugs.
  • History of heavy alcohol use/binge drinking,
  • Have planned procedures with radiological contrast,
  • Have a major dental procedure/surgery coming up, such as a dental extraction
  • Anatomy of the middle cerebral artery or internal carotid artery that prevents adequate ultrasonography and/or and data collection

Study Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Vascular Tests

All women will complete the same protocol, regardless of pregnancy history.

Interventions

Intradermal Microdialysis

A total of three microdialysis sites will be perfused with ringer's solution, L-NAME, or ketorolac (one drug per site). After a baseline period, all three sites will undergo tests of blood vessel function including an acetylcholine dose-response protocol and a test of maximal skin blood flow with sodium nitroprusside.

Brain Blood Flow Tests

Participants will complete CO2 breathing procedures to evaluate brain blood vessel health.

Local Heating

A dime-sized heater will be placed on the skin to evaluate cutaneous microvascular function

Primary outcome measure

  • Stepped hypercapnia-induced change in middle cerebral artery velocity [ Time Frame: During the study visit, an average of 5 hours ]
  • Hypercapnia-induced change in internal carotid artery diameter [ Time Frame: During the study visit, an average of 5 hours ]
  • Change in microvascular blood flow response to increasing concentrations of acetylcholine [ Time Frame: During the study visit, an average of 5 hours ]

Central Contacts and Locations

Central contacts

Anna Reid-Stanhewicz, PHD

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

Locations

Iowa Bioscience Innovation Facility

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Anna Stanhewicz, P.h.D

3194671732anna-stanhewicz@uiowa.edu

Claire Goebel, B.S.

5158359904cgoebl@uiowa.edu

More Information

Sponsor

Anna Stanhewicz, PhD

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • Gestational Diabetes
  • Brain Blood Flow
  • Pregnancy
  • Postpartum

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Anna Stanhewicz, PhD on 2025-12-16.