Gestational Diabetes for Cerebrovascular Function After Pregnancy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how gestational diabetes (a type of diabetes that occurs during pregnancy) affects blood flow in the brain after pregnancy. Researchers will use ultrasound to examine brain blood flow and assess how the brain's blood vessels react to increased carbon dioxide, similar to holding one's breath. The study will also compare these results with skin blood flow tests, including intradermal microdialysis (a technique to measure substances in the skin) and local heating, to explore possible connections. Women who have had gestational diabetes or an uncomplicated pregnancy in the past five years may be eligible to participate. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking scientific knowledge.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications, including NSAIDs, statins, cholesterol-lowering medications, antihypertensive medications, carbonic anhydrase inhibitors, corticosteroids, thyroid medications, antidepressants, mood stabilizers, diuretics, phenothiazines, and benzodiazepines.
What prior data suggests that these brain blood flow tests and intradermal microdialysis are safe?
Research has shown that the treatments tested in this trial for gestational diabetes are generally safe and easy for participants to handle. The brain blood flow tests use ultrasound, a common and painless method, to check how blood moves through the brain. These tests are widely used in many medical settings and are known to be safe.
The other technique tested, called intradermal microdialysis, uses a simple method to deliver tiny amounts of medicine to the skin. Previous studies have used this technique without major side effects, indicating it is well-tolerated.
Since this is an early-phase study, the main focus is on safety. Researchers remain very careful and watchful for any side effects. While specific safety data from this trial is not yet available, similar studies have shown that these methods are safe for participants.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how gestational diabetes might affect brain blood flow after pregnancy, which is a relatively uncharted area. Standard treatments for gestational diabetes typically focus on managing blood sugar levels during pregnancy, but this study looks at long-term vascular impacts. The trial uses innovative techniques like brain blood flow tests and intradermal microdialysis to gather detailed insights. These methods could reveal connections between gestational diabetes and cerebrovascular health, potentially leading to new ways to monitor and manage risks in women after pregnancy.
What evidence suggests that this trial's treatments could be effective for cerebrovascular function after gestational diabetes?
Research shows that women who have had gestational diabetes (GDM) often experience issues with their blood vessels, affecting tiny vessels in both the brain and skin. Studies indicate that the brain might try to cope by increasing blood flow, but problems can still arise over time. In this trial, all participants will follow the same protocol, including Brain Blood Flow Tests and Intradermal Microdialysis, to measure these changes. Previous findings suggest that even when blood sugar levels return to normal, blood vessels may not function optimally. Factors like oxidative stress, which can damage blood vessels, might contribute to this issue.34678
Are You a Good Fit for This Trial?
This trial is for women who gave birth within the last 5 years and had either gestational diabetes as per ACOG criteria or a normal pregnancy without complications like hypertension. It's not suitable for those with other gestational disorders.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Vascular Tests
Participants undergo non-invasive ultrasound measurements of brain blood flow and skin microvascular function assessments
Follow-up
Participants are monitored for safety and effectiveness after the vascular tests
What Are the Treatments Tested in This Trial?
Interventions
- Brain Blood Flow Tests
- Intradermal Microdialysis
- Local Heating
Trial Overview
The study investigates how gestational diabetes affects brain blood flow and vessel function post-pregnancy, using non-invasive ultrasounds and skin microvascular tests to compare results between affected and healthy women.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
All women will complete the same protocol, regardless of pregnancy history.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Anna Stanhewicz, PhD
Lead Sponsor
Citations
1.
clinicaltrials.uihealthcare.org
clinicaltrials.uihealthcare.org/studies/impact-gestational-diabetes-mellitus-cerebral-blood-flow-and-cerebrovascular-functionThe Impact of Gestational Diabetes Mellitus on Cerebral Blood ...
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 ...
Fetal Cerebrovascular Flow Index from Three-Dimensional ...
The findings suggest that fetal brains in GDM cases adapt by increasing blood flow, as indicated by FI and VFI, while medication reduces pathological cerebral ...
MV-Flow imaging for evaluating the placental function ...
Placental microvascular blood flow can be visualized and quantified in women with GDM using MV-Flow. Keywords: microvascular flow imaging, ...
Article Investigating cerebral neurovascular responses to ...
Increased local blood supply is critical for brain function, and damaged NVC may play an early role in triggering cognitive dysfunction in T2DM ...
The assessment of fetal brain growth in diabetic pregnancy ...
To assess fetal brain growth over the third trimester in pregnant women with diabetes using in utero magnetic resonance imaging (iuMRI) to determine if greater ...
The Impact of Gestational Diabetes Mellitus on Cerebral ...
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to ...
Brain Development in Fetuses of Mothers with Diabetes
Abstract. BACKGROUND AND PURPOSE: Offspring exposed to maternal diabetes are at increased risk of neurocognitive impairment, but its origins are unknown.
A Review of the Impact of Gestational Diabetes on Fetal ...
A pilot study of 20 newborns with GDM mothers revealed differences in neonatal EEG patterns compared to controls, suggestive of altered brain function [35]. ...
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