Clinical Trial

Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM

Recruiting Early Phase 1
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Summary
Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined. The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.
Protocol Amendment History 1 change
notable Primary completion pushed: 2026-05 -> 2026-09 2026-07-30
Trial Details
NCT Number NCT06547619
Lead Sponsor Anna Stanhewicz, PhD
Conditions Gestational Diabetes, Endothelial Dysfunction, Physical Inactivity
Enrollment 40 participants
Start Date 2024-10-01
Primary Completion 2026-09 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-29