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

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Anna Stanhewicz, PhD
Study ID
NCT06911372
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Intradermal Microdialysis — DRUG
    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 — OTHER
    Participants will complete CO2 breathing procedures to evaluate brain blood vessel health.
  • Local Heating — OTHER
    A dime-sized heater will be placed on the skin to evaluate cutaneous microvascular function

Study Details

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.

Key Dates

Start date
Aug 22, 2025
Status verified
Dec 2025
Primary completion
Apr 15, 2027
Completion
Apr 15, 2028

Study Design

Enrollment
84 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Vascular Tests
    All women will complete the same protocol, regardless of pregnancy history.

Primary Outcome Measure

Stepped hypercapnia-induced change in middle cerebral artery velocity [ Time Frame: During the study visit, an average of 5 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Iowa Bioscience Innovation FacilityIowa CityIowa52242
Anna Stanhewicz, P.h.D
[email protected]
3194671732
Claire Goebel, B.S.
[email protected]
5158359904

Find similar trials in Iowa City, IA

By research site
Iowa Bioscience Innovation Facility· Iowa City, IA

Related Studies