Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: PCOS, Offspring, Adult, Hyperandrogenism, Epigenetics. Базовые параметры: до 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- 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
Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study
Обзор
The Offspring Born to Mothers with Polycystic Ovary Syndrome in Guangzhou Cohort study (PCOS-BIG) was established to investigate the short- and long-term effects of intrauterine exposure to maternal PCOS on the health of offspring in Guangzhou, China. Data are collected regarding maternal PCOS subtypes, nursing, diet and education as well as health outcomes in their later life. Biological samples including blood and tissue samples are also collected from participants.
Подробное описание
According to preliminary survey, the prevalence of polycystic ovary syndrome (PCOS) among Chinese women reached 7.5%. Hyperandrogenism and insulin resistance were considered as the main pathogenesis of PCOS. As reported, the secretion of androgen is higher among women with PCOS than the healthy reference population throughout their fertile lives. Worth of concern, offspring of PCOS patients presented with glucolipid metabolism disorders as early as during their childhood, while whose pathogenesis remains unclear. Prenatal exposure of rhesus monkey in pregnant to androgens produces glucolipid metabolic alterations in offspring resembling those in PCOS, suggesting that the exposure of the fetus to hyperandrogenism during gestation could affect the glucolipid metabolism of PCOS offspring. Growing evidence shows that different exposures during pregnancy will affect the DNA methylation of offspring and disturb their endocrine and metabolism. A birth cohort would provide an opportunity to examine the short- and long-term effects of PCOS exposure, such as hyperandrogenism, on health consequences of the offspring.
Первичные конечные точки
- Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) [Срок оценки: An average of 3 years old]
Вторичные конечные точки (12)
- Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section [Срок оценки: From the recruitment (≤ 20 weeks of gestation) to delivery]
- Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect [Срок оценки: At delivery]
- Epigenetic profiles of offspring [Срок оценки: At birth]
- Weight changes [Срок оценки: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
- Height changes [Срок оценки: At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
- Change of intestinal flora [Срок оценки: At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old]
- Neurodevelopment at early childhood [Срок оценки: At age of 1 year old]
- Changes of the percentage of body fat [Срок оценки: At age of 3 years,6 years, 12 years and 18 years old]
- Screen of intelligence quotient of offspring [Срок оценки: At age of 6 years old]
- Intelligence quotient of offspring assessed by WPPSI-IV [Срок оценки: At age of 6 years old]
- Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders) [Срок оценки: At age of 6 years, 12 years and 18 years old]
- Number of participants with reproductive endocrine disorders [Срок оценки: At age of 12 years and 18 years old]
Критерии участия
Критерии включения
- Offspring born to women diagnosed with PCOS
- Offspring born to women with <20 weeks of gestation, intended to eventually deliver in Guangzhou Women and Children's Medical Center
- Permanent residents or families intended to remain in Guangzhou for ≥3 years
Критерии исключения
- None
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Guangzhou Women and Children's Medical Center, China — Гуанчжоу
Публикации
- Zhou Z, Li R, Qiao J. Androgen profile in Chinese women with polycystic ovary syndrome in their reproductive years. Reprod Biomed Online. 2017 Sep;35(3):331-339. doi: 10.1016/j.rbmo.2017.05.019. Epub 2017 Jun 16. PMID 28684272
- Qiu X, Lu JH, He JR, Lam KH, Shen SY, Guo Y, Kuang YS, Yuan MY, Qiu L, Chen NN, Lu MS, Li WD, Xing YF, Zhou FJ, Bartington S, Cheng KK, Xia HM. The Born in Guangzhou Cohort Study (BIGCS). Eur J Epidemiol. 2017 Apr;32(4):337-346. doi: 10.1007/s10654-017-0239-x. Epub 2017 Mar 20. PMID 28321694
Идентификаторы
NCT: NCT03742011 · 2018101502