An Early Phase 1 interventional study of Acetylcholine and insulin aspart in Gestational Diabetes and Vascular Endothelial Function, sponsored by Anna Stanhewicz, PhD. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Anna Stanhewicz, PhD · Early Phase 1, Interventional, and Basic science
The purpose of this investigation is to examine the role of oxidative stress in aberrant microvascular function in otherwise healthy women with a history of GDM.
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 oxidative stress in mediating vascular dysfunction in women who have had gestational diabetes.
In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure markers of oxidative stress and insulin-mediated eNOS phosphorylation in these cells.
842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.
This study's planned enrollment of 28 is below the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Anna Stanhewicz, PhD is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
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EXCLUSION CRITERIA:
lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control
Drug: Acetylcholine · Drug: insulin aspart
local ascorbate is perfused through the microdialysis fiber to serve as the antioxidant experimental treatment
Drug: Acetylcholine · Drug: insulin aspart
local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase
Drug: Acetylcholine · Drug: insulin aspart
acetylcholine is perfused at 10 ascending concentrations (10\^-10M - 10\^-1 M) for 5 minutes each
insulin aspart is perfused at 5 ascending concentrations (10\^-8M - 10\^-4 M) for 10 minutes each
microvascular acetylcholine-mediated dilation
cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, ascorbate, and L-NAME treated microdialysis sites
Time frame: at the study visit, an average of 4 hours
microvascular insulin-mediated dilation
cutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, ascorbate, and L-NAME treated microdialysis sites
Time frame: at the study visit, an average of 4 hours
endothelial cell markers of oxidative stress
nitrotyrosine, MnSOD and NADPH oxidase expression in biopsied endothelial cells
Time frame: at the study visit, an average of 4 hours
endothelial cell insulin-stimulated eNOS phosphorylation
eNOS phosphorylation response to incubation with insulin in biopsied endothelial cells
Time frame: at the study visit, an average of 4 hours
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Anna Stanhewicz, PhD