Clinical trial

Role of NADPH Oxidase in Microvascular Dysfunction Following GDM

Name

202303158

Description

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 arms

Trial start

2023-08-30

Estimated PCD

2026-06-01

Trial end

2027-06-01

Status

Recruiting

Phase

Early phase I

Treatment

Acetylcholine

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

Arms:

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

Insulin aspart

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

Arms:

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

Size

Primary endpoint

microvascular acetylcholine-mediated dilation

at the study visit, an average of 4 hours

microvascular insulin-mediated dilation

at the study visit, an average of 4 hours

Eligibility criteria

INCLUSION CRITERIA: * 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 EXCLUSION CRITERIA: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-09-14

1 organization

Organization

Anna Stanhewicz