The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy
NCT ID: NCT06911372
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
84 participants
INTERVENTIONAL
2025-08-22
2028-04-15
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Vascular Tests
All women will complete the same protocol, regardless of pregnancy history.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
FEMALE
Yes
Sponsors
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Anna Stanhewicz, PhD
OTHER
Responsible Party
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Anna Stanhewicz, PhD
Assistant Professor
Locations
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Iowa Bioscience Innovation Facility
Iowa City, Iowa, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202410260
Identifier Type: -
Identifier Source: org_study_id