The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy
Key facts
- Who runs it
- Anna Stanhewicz, PhD
- Where
- Iowa City, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 84 people, planned
- Started
- 22 Aug 2025
- Expected to end
- 15 Apr 2028
- Type of study
- Interventional
- Treatments tested
- Intradermal Microdialysis
- Brain Blood Flow Tests
- Local Heating
- Record updated
- 16 December 2025
Who can take part
- Age
- 18 years to 50 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- Have a major dental procedure/surgery coming up, such as a dental extraction
- Skin diseases
- 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
- History of preeclampsia or gestational hypertension,
- History or family history of panic disorder,
- Allergy to materials used during the experiment (e.g. latex), known allergies to study drugs
- History of heavy alcohol use/binge drinking,
- Current tobacco use
- Currently pregnant
- Body mass index <18.5 kg/m2,
- Have planned procedures with radiological contrast,
- Anatomy of the middle cerebral artery or internal carotid artery that prevents adequate ultrasonography and/or and data collection
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Where in United States
- Iowa Bioscience Innovation FacilityIowa City, United StatesContact: Anna Stanhewicz, P.h.DTaking people
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Vascular TestsTreatment being tested
All women will complete the same protocol, regardless of pregnancy history.
Treatment: Intradermal Microdialysis, Brain Blood Flow Tests, and Local Heating
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT06911372, who can take part
- Record updated
- 16 December 2025