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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06911372
Enrollment
84
Registered
2025-04-04
Start date
2025-08-22
Completion date
2028-04-15
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes Mellitus (GDM), Postpartum Women, Uncomplicated Pregnancy

Keywords

Gestational Diabetes, Brain Blood Flow, Pregnancy, Postpartum

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.

Interventions

DRUGIntradermal 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.

OTHERBrain Blood Flow Tests

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

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

Sponsors

Anna Stanhewicz, PhD
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Stepped hypercapnia-induced change in middle cerebral artery velocityDuring the study visit, an average of 5 hoursMiddle cerebral artery velocity responses to stepped concentrations of inhaled carbon dioxide gas
Hypercapnia-induced change in internal carotid artery diameterDuring the study visit, an average of 5 hoursInternal carotid artery shear-mediated dilation response to inhaled carbon dioxide
Change in microvascular blood flow response to increasing concentrations of acetylcholineDuring the study visit, an average of 5 hoursCutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, ketorolac, and L-NAME treated microdialysis sites.

Countries

United States

Contacts

Primary ContactAnna Reid-Stanhewicz, PHD
anna-stanhewicz@uiowa.edu319-467-1732

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026