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NCT06911372 · ClinicalTrials.gov registry record · Phase 1
The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy
A Phase 1 study of Gestational Diabetes Mellitus (GDM) and Postpartum Women, sponsored by Anna Stanhewicz, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT06911372 is a Phase 1 study of Gestational Diabetes Mellitus (GDM) and Postpartum Women that is actively recruiting participants, run by Anna Stanhewicz, PhD. The registered enrollment target is 84 participants, below the 822-participant average among 4 other Gestational Diabetes Mellitus (GDM) trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06911372, a Phase 1 study of Gestational Diabetes Mellitus (GDM) and Postpartum Women, is actively recruiting participants, sponsored by Anna Stanhewicz, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Intradermal Microdialysis
- OTHER Brain Blood Flow Tests
- OTHER Local Heating
Study Locations (1)
Iowa
- Iowa Bioscience Innovation Facility - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2025-08-22 |
| Est. Completion | 2028-04-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06911372
The ClinicalTrials.gov registry entry for NCT06911372 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 822-participant average among 4 other Gestational Diabetes Mellitus (GDM) trials with a reported enrollment target (90% lower). The listed sponsor is Anna Stanhewicz, PhD, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Gestational Diabetes Mellitus (GDM) appearing as the primary indexed condition, and to 3 interventions - of which Intradermal Microdialysis is the first listed.
NCT06911372 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT06911372 about?
NCT06911372 is a clinical study titled "The Impact of Gestational Diabetes Mellitus on Cerebral Blood Flow and Cerebrovascular Function After Pregnancy". 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...
What is the current status of trial NCT06911372?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2025-08-22. Estimated completion is 2028-04-15.
What conditions does trial NCT06911372 study?
This clinical trial studies the following conditions: Gestational Diabetes Mellitus (GDM), Postpartum Women, Uncomplicated Pregnancy.
What interventions are being tested in trial NCT06911372?
The interventions under investigation include: Intradermal Microdialysis (DRUG), Brain Blood Flow Tests (OTHER), Local Heating (OTHER).
Who is sponsoring clinical trial NCT06911372?
This trial is sponsored by Anna Stanhewicz, PhD, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06911372 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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