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Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

ConditionsGestational DiabetesOxidative StressVascular Endothelial Function
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorAnna Stanhewicz, PhD

About this trial

The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 years or older

pregnant within 5 years of the study visit

had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes.

or without a history of gestational diabetes

Disqualifiers

skin diseases

current tobacco or electronic cigarette/vape pen use,

diagnosed or suspected hepatic or metabolic disease including diabetes,

statin or other cholesterol-lowering medication,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acetylcholine

    Drug

    acetylcholine is perfused at 10 ascending concentrations (10\^-10M - 10\^-1 M) for 5 minutes each

  • Insulin aspart

    Drug

    insulin aspart is perfused at 5 ascending concentrations (10\^-8M - 10\^-4 M) for 10 minutes each

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: local lactated Ringer's perfusionPlacebo comparator 2 interventions
Group B: local apocynin perfusionExperimental treatment 2 interventions
Group C: local L-NAME perfusionExperimental treatment 2 interventions
Group D: local apocynin + L-NAME perfusionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

microvascular acetylcholine-mediated dilation

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

Time frame
at the study visit, an average of 4 hours
2

microvascular insulin-mediated dilation

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

Time frame
at the study visit, an average of 4 hours

Secondary outcomes

1

endothelial cell NADPH oxidase expression

NADPH oxidase expression in biopsied endothelial cells

Time frame
at the study visit, an average of 4 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Stanhewicz, PhD

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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