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

Phase 1

Not yet recruiting

• Conditions: Gestational Diabetes Mellitus (GDM); Postpartum Women; Uncomplicated Pregnancy
• Interventions: Drug: Intradermal Microdialysis; Other: Brain Blood Flow Tests; Other: Local Heating

• Registration Number: NCT06911372
• Lead Sponsor: Anna Stanhewicz, PhD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-04-04
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-31
• Study Start: 2025-08-15
• Primary Completion: 2027-04-15
• Study Completion: 2028-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vascular Tests	Intradermal Microdialysis	All women will complete the same protocol, regardless of pregnancy history.
Vascular Tests	Brain Blood Flow Tests	All women will complete the same protocol, regardless of pregnancy history.
Vascular Tests	Local Heating	All women will complete the same protocol, regardless of pregnancy history.

Primary Outcome Measures

Name	Time	Method
Stepped hypercapnia-induced change in middle cerebral artery velocity	During the study visit, an average of 5 hours	Middle cerebral artery velocity responses to stepped concentrations of inhaled carbon dioxide gas
Hypercapnia-induced change in internal carotid artery diameter	During the study visit, an average of 5 hours	Internal carotid artery shear-mediated dilation response to inhaled carbon dioxide
Change in microvascular blood flow response to increasing concentrations of acetylcholine	During the study visit, an average of 5 hours	Cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, ketorolac, and L-NAME treated microdialysis sites.