Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study

Insulin Resistance Clinical Trial

— PCOS-BIG  

Official title:

Health of Offspring Born to Mothers With Polycystic Ovary Syndrome in Guangzhou Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03742011
• Other study ID #: 2018101502
• Status: Recruiting
• Start date: February 1, 2012
• Est. completion date: December 31, 2038

Study information

• Verified date: February 2024
• Source: Guangzhou Women and Children's Medical Center
• Contact: Xiu Qiu, PhD
• Phone: 0086 20 38367160
• Email: qxiu0161[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Endocrine Disorder
• Endocrine System Diseases
• Epigenetics
• Hyperandrogenism
• Insulin Resistance
• Metabolic Disturbance
• Offspring, Adult
• PCOS
• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
China	Guangzhou Women and Children's Medical Center, China	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center	University of Birmingham

Country where clinical trial is conducted

China, 

References & Publications (2)

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/s10654-017-02 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)	Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.	An average of 3 years old
Secondary	Prevalence of gestational diabetes, pregnancy induced hypertension, and cesarean section	Assessed by self-reported time of onset and electronic medical records	From the recruitment (= 20 weeks of gestation) to delivery
Secondary	Prevalence of stillbirth, preterm birth, small for gestational age, large for gestational age and birth defect	Assessed by electronic medical records	At delivery
Secondary	Epigenetic profiles of offspring	Profiling DNA methylation and histone acetylation etc., using cord blood samples	At birth
Secondary	Weight changes	Weight changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old	At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Secondary	Height changes	Height changes from birth, to age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old	At birth, age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Secondary	Change of intestinal flora	Assessed by analyses of stool samples	At age of 6 weeks, 6 months, 1 year, 3 years, 6 years, 12 years and 18 years old
Secondary	Neurodevelopment at early childhood	Assessed using Gesell Developmental Schedules, including five items of adaptive, gross motor, fine motor, language, and social function	At age of 1 year old
Secondary	Changes of the percentage of body fat	Assessed using Dual Energy X-Ray Absorptiometry	At age of 3 years,6 years, 12 years and 18 years old
Secondary	Screen of intelligence quotient of offspring	Assessed using Peabody Picture Vocabulary Test (PPVT) and Raven's Standard Progressive Matrices (SPM). Of whom the score of PPVT = 85 and the score of SPM = 90, the child will be considered as normal level of intelligence quotient and of whom the score of PPVT under 85 or the score of SPM under 90 will be considered as suspected lower intelligence quotient.	At age of 6 years old
Secondary	Intelligence quotient of offspring assessed by WPPSI-IV	Child screened as of suspected lower intelligence quotient will be assessed by Wechsler Preschool and Primary Scale of Intelligence-Fourth edition (WPPSI-IV), including 5 items: verbal comprehension, visual spatial, fluid reasoning, working memory and process speed. Scores of the five items are added to get the total score.	At age of 6 years old
Secondary	Number of Participants With Abnormal Laboratory Values (Glucolipid metabolism disorders)	Participants with one or more abnormal laboratory values will be considered as with glucolipid metabolism disorder.	At age of 6 years, 12 years and 18 years old
Secondary	Number of participants with reproductive endocrine disorders	Assessed by assay of hormones, including follicle stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), total testosterone (TT), free testosterone (FT), androstenedione (A4), dehydroepiandrosterone sulfate (DHEA-S) and sex hormone binding globulin (SHBG), and by acne scoring and hirsutism scoring (modified Ferriman-Gallway scoring system). Participants with one or more abnormal laboratory values, and/or acne score = 1, and/or hirsutism score = 5 will be considered as with reproductive endocrine disorder.	At age of 12 years and 18 years old