MedPath

Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

Early Phase 1
Recruiting
Conditions
Vascular Endothelial Function
Gestational Diabetes
Interventions
Registration Number
NCT05946785
Lead Sponsor
Anna Stanhewicz, PhD
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
28
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
local lactated Ringer's perfusioninsulin aspartlactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control
local L-NAME perfusioninsulin aspartlocal L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase
local ascorbate perfusionAcetylcholinelocal ascorbate is perfused through the microdialysis fiber to serve as the antioxidant experimental treatment
local ascorbate perfusioninsulin aspartlocal ascorbate is perfused through the microdialysis fiber to serve as the antioxidant experimental treatment
local L-NAME perfusionAcetylcholinelocal L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase
local lactated Ringer's perfusionAcetylcholinelactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control
Primary Outcome Measures
NameTimeMethod
microvascular acetylcholine-mediated dilationat the study visit, an average of 4 hours

cutaneous vascular vasodilator responses to acetylcholine perfusion in lactated Ringer's, ascorbate, and L-NAME treated microdialysis sites

microvascular insulin-mediated dilationat the study visit, an average of 4 hours

cutaneous vascular vasodilator responses to insulin perfusion in lactated Ringer's, ascorbate, and L-NAME treated microdialysis sites

Secondary Outcome Measures
NameTimeMethod
endothelial cell markers of oxidative stressat the study visit, an average of 4 hours

nitrotyrosine, MnSOD and NADPH oxidase expression in biopsied endothelial cells

endothelial cell insulin-stimulated eNOS phosphorylationat the study visit, an average of 4 hours

eNOS phosphorylation response to incubation with insulin in biopsied endothelial cells

Trial Locations

Locations (1)

University of Iowa

🇺🇸

Iowa City, Iowa, United States

© Copyright 2025. All Rights Reserved by MedPath