Clinical trial

Role of Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes

Name

202009357

Description

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.

Trial arms

Trial start

2023-07-01

Estimated PCD

2026-01-01

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 ascorbate 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 ascorbate 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: * 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 * or without a history of gestational diabetes EXCLUSION CRITERIA: * skin diseases * current tobacco/e-cigarette 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': 28, 'type': 'ESTIMATED'}}

Updated at

2024-05-16

1 organization

Organization

Anna Stanhewicz