How gestational diabetes affects brain blood flow after pregnancy
The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy
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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Iowa Academic / other |
| Locations | 1 site (Iowa City, Iowa) |
| Trial ID | NCT06911372 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Iowa City, Iowa
- Iowa Bioscience Innovation Facility — Iowa City, Iowa, United States (Recruiting)
Study contacts
- Study coordinator: Anna Reid-Stanhewicz, PHD
- Email: anna-stanhewicz@uiowa.edu
- Phone: 319-467-1732
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.