Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
Anna Stanhewicz, PhD
Study ID
NCT05946798
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Gestational Diabetes
  • Oxidative Stress
  • Vascular Endothelial Function

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Aug 30, 2023
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Placebo Comparator: local lactated Ringer's perfusion
    lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control
  • Experimental: local apocynin perfusion
    local apocynin is perfused through the microdialysis fiber to serve as the NADPH oxidase inhibited experimental treatment
  • Experimental: local L-NAME perfusion
    local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase
  • Experimental: local apocynin + L-NAME perfusion
    local apocynin and L-NAME are perfused through the microdialysis fiber for dual inhibition of NADPH oxidase and nitric oxide synthase

Primary Outcome Measure

microvascular acetylcholine-mediated dilation [ Time Frame: at the study visit, an average of 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Anna Stanhewicz, PhD
[email protected]
319-467-1732

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By research site
University of Iowa· Iowa City, IA

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