Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acetylcholine, insulin aspart.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes, Vascular Endothelial Function. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Role of Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes
Overview
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.
Detailed description
Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.
The purpose of this investigation is to examine the role of oxidative stress in mediating vascular dysfunction in women who have had gestational diabetes.
In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had GDM. As a compliment to these measures, the investigators also collect endothelial cells from an antecubital vein and measure markers of oxidative stress and insulin-mediated eNOS phosphorylation in these cells.
Interventions
- Drug Acetylcholine
acetylcholine is perfused at 10 ascending concentrations (10\^-10M - 10\^-1 M) for 5 minutes each - Drug insulin aspart
insulin aspart is perfused at 5 ascending concentrations (10\^-8M - 10\^-4 M) for 10 minutes each
Primary outcome measures
- microvascular acetylcholine-mediated dilation [Time frame: at the study visit, an average of 4 hours]
- microvascular insulin-mediated dilation [Time frame: at the study visit, an average of 4 hours]
Secondary outcome measures (2)
- endothelial cell markers of oxidative stress [Time frame: at the study visit, an average of 4 hours]
- endothelial cell insulin-stimulated eNOS phosphorylation [Time frame: 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Iowa — Iowa City
Identifiers
NCT: NCT05946785 · 202009357 · 1R01HL169201-01