Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes
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 the role of oxidative stress in aberrant microvascular function in otherwise healthy women with a history of GDM.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
female sex
18 -50 years old
pregnancy history 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
Disqualifiers
skin diseases
current tobacco/e-cigarette 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
Drugacetylcholine is perfused at 10 ascending concentrations (10\^-10M - 10\^-1 M) for 5 minutes each
insulin aspart
Druginsulin aspart is perfused at 5 ascending concentrations (10\^-8M - 10\^-4 M) for 10 minutes each
Treatment groups
28 Participants
are divided into 3 treatment groupsGroup A: local lactated Ringer's perfusionPlacebo comparator 2 interventions
Group B: local ascorbate perfusionExperimental treatment 2 interventions
Group C: local 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, ascorbate, and L-NAME treated microdialysis sites
Time frame
at the study visit, an average of 4 hours2
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 hoursSecondary outcomes
1
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 hours2
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 hoursSponsors 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