Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Acetylcholine, insulin aspart.
- Кому может быть актуально
- Состояния в реестре: Gestational Diabetes, Vascular Endothelial Function. Базовые параметры: 18 лет — 50 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Role of Oxidative Stress in Microvascular Dysfunction Following Gestational Diabetes
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Acetylcholine
acetylcholine is perfused at 10 ascending concentrations (10\^-10M - 10\^-1 M) for 5 minutes each - Препарат insulin aspart
insulin aspart is perfused at 5 ascending concentrations (10\^-8M - 10\^-4 M) for 10 minutes each
Первичные конечные точки
- microvascular acetylcholine-mediated dilation [Срок оценки: at the study visit, an average of 4 hours]
- microvascular insulin-mediated dilation [Срок оценки: at the study visit, an average of 4 hours]
Вторичные конечные точки (2)
- endothelial cell markers of oxidative stress [Срок оценки: at the study visit, an average of 4 hours]
- endothelial cell insulin-stimulated eNOS phosphorylation [Срок оценки: at the study visit, an average of 4 hours]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Нерандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Фундаментальное исследование
Центры проведения
США · 1 центр
- University of Iowa — Iowa City
Идентификаторы
NCT: NCT05946785 · 202009357 · 1R01HL169201-01