NCT05946798

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
25mo left

Started Aug 2023

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Aug 2023Jun 2028

First Submitted

Initial submission to the registry

June 29, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

3.8 years

First QC Date

June 29, 2023

Last Update Submit

May 7, 2025

Conditions

Gestational DiabetesOxidative StressVascular Endothelial Function

Keywords

gestational diabetespostpartumvascular

Outcome Measures

Primary Outcomes (2)

  • 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

    at the study visit, an average of 4 hours

  • 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

    at the study visit, an average of 4 hours

Secondary Outcomes (1)

  • endothelial cell NADPH oxidase expression

    at the study visit, an average of 4 hours

Study Arms (4)

local lactated Ringer's perfusion

PLACEBO COMPARATOR

lactated Ringer's is perfused through the microdialysis fiber to serve as the vehicle control

Drug: AcetylcholineDrug: Insulin aspart

local apocynin perfusion

EXPERIMENTAL

local apocynin is perfused through the microdialysis fiber to serve as the NADPH oxidase inhibited experimental treatment

Drug: AcetylcholineDrug: Insulin aspart

local L-NAME perfusion

EXPERIMENTAL

local L-NAME is perfused through the microdialysis fiber to inhibit nitric oxide synthase

Drug: AcetylcholineDrug: Insulin aspart

local apocynin + L-NAME perfusion

EXPERIMENTAL

local apocynin and L-NAME are perfused through the microdialysis fiber for dual inhibition of NADPH oxidase and nitric oxide synthase

Drug: AcetylcholineDrug: Insulin aspart

Interventions

AcetylcholineDRUG

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

local L-NAME perfusionlocal apocynin + L-NAME perfusionlocal apocynin perfusionlocal lactated Ringer's perfusion
Insulin aspartDRUG

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

local L-NAME perfusionlocal apocynin + L-NAME perfusionlocal apocynin perfusionlocal lactated Ringer's perfusion

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • current antihypertensive medication,
  • history of preeclampsia or gestational hypertension,
  • current pregnancy,
  • body mass index \<18.5 kg/m2,
  • allergy to materials used during the experiment.(e.g. latex),
  • known allergies to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

AcetylcholineInsulin Aspart

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biogenic AminesAminesOrganic ChemicalsInsulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Central Study Contacts

Anna Reid-Stanhewicz, PHD

CONTACT

319-467-1732anna-stanhewicz@uiowa.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 14, 2023

Study Start

August 30, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations

US(1)