Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 50 Women only

How gestational diabetes affects brain blood flow after pregnancy

Official title: The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy

Run by University of Iowa · NCT06911372 · Data updated 2026-11-12

This study will test whether a past diagnosis of gestational diabetes changes brain blood flow and blood-vessel function in women within five years after giving birth.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 50 Years
SexWomen only
Enrollment84 (estimated)
SponsorUniversity of Iowa
Academic / other
Locations1 site (Iowa City, Iowa)
StatusRecruiting
StartedAugust 22, 2025
Main results expectedApril 15, 2027
Study endsApril 15, 2028
Registry record updatedDecember 16, 2025
Trial IDNCT06911372 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy postpartum women aged 18 or older who delivered within five years and either had gestational diabetes diagnosed by standard criteria or had an uncomplicated pregnancy, and who do not have current diabetes or other excluded conditions or medications.

Probably not a fit

Women with current diabetes, active hepatic/metabolic/lung disease, diagnosed mood disorders, current tobacco use, significant skin disease, or who take excluded medications are unlikely to be eligible or to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will compare healthy postpartum women with a history of gestational diabetes to those with an uncomplicated pregnancy using noninvasive cerebral blood flow measurements and targeted microvascular testing. The protocol uses two types of ultrasound to measure cerebral hemodynamics and intradermal microdialysis with local heating to probe peripheral microvascular function as a mechanistic correlate. Participants must be at least 18 years old, delivered within the past five years, and free of current diabetes or several excluded medical conditions and medications. This Phase 1 interventional protocol is focused on physiological measurements to characterize cerebrovascular changes after gestational diabetes rather than testing a therapeutic intervention.

Why it matters

Potential benefit: If successful, the findings could reveal vascular changes after gestational diabetes that inform strategies to reduce later stroke and dementia risk.

How similar studies have gone: Prior studies have shown impaired skin microvascular function after gestational diabetes and ultrasound has been used to study cerebral blood flow in other populations, but applying these cerebrovascular tests specifically to postpartum GDM is largely novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Iowa Bioscience Innovation Facility
    Iowa City, Iowa, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.