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Maternal Endocrine System and Metabolic Diseases and Offspring Health: Prediction Within a Birth Cohort

NCT ID: NCT05952739

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-09-30

Brief Summary

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The incidence of metabolic diseases in pregnant women is increasing rapidly, and the risk of metabolic diseases in children is also increasing. However, there is a lack of early predictive indicators for metabolic diseases in children, which cannot effectively prevent and treat metabolic diseases in children. This project will establish a clinical database and a long-term follow-up biological bio-bank through the follow-up of metabolic indicators before and during pregnancy, and form an early warning system for the effects of maternal endocrine and metabolic diseases on the metabolism of offspring. It will not only help to warn the impact of maternal endocrine system and metabolic diseases on the metabolism of offspring, but also build a transformation platform for the study of maternal endocrine and metabolic diseases and metabolic health of offspring, which has important clinical value for curbing the rapid growth of metabolic diseases such as diabetes and obesity in China. It is expected to provide an important theoretical basis for the window period of prevention and treatment of endocrine and metabolic diseases in China.

Detailed Description

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Due to the rapid changes in the environment and lifestyle, women of childbearing age often suffer from endocrine and metabolic diseases such as diabetes and thyroid diseases, resulting in poor intrauterine development environment in the early life. Maternal endocrine metabolic diseases and nutritional status not only affect their own health, but also greatly affect the metabolic health of their offspring. Hyperglycemia and thyroid dysfunction during pregnancy can increase the risk of obesity, metabolic syndrome and diabetes in offspring. The developmental origin of health and disease (DOHaD) is a well-known theory about the effect of early developmental environment (fetus and newborn) on the metabolic health of offspring. Several well-known international birth cohorts have confirmed that maternal malnutrition during pregnancy can lead to an increased risk of metabolic diseases in adult offspring. Previously, Xiao 's team found that low birth weight was an independent risk factor for abnormal glucose and lipid metabolism in adulthood through the 'Concord birth-old age' cohort study, which confirmed the DOHaD theory for the first time in the Chinese population. The above retrospective cohort study provides epidemiological evidence for the DOHaD theory. However, due to its early start and the lack of a comprehensive database of clinical data and biological samples at different stages of the subjects' lives, it is difficult to deeply analyze the high-risk factors of metabolic abnormalities in offspring, and it is difficult to effectively intervene and block the 'origin of metabolic diseases' from the early stage of life development. In addition, cross-generational studies at home and abroad are mostly retrospective and cross-sectional studies, with selection bias and information bias. Prospective birth cohort studies covering the whole life cycle of maternal endocrine and metabolic diseases are urgently needed. This project will continue to focus on the endocrine system and metabolic diseases of women of childbearing age in this large birth cohort, and cooperate with the Department of Endocrinology, Obstetrics, Pediatrics and Nutrition of Peking Union Medical College Hospital to construct a large-scale prospective cohort of maternal endocrine and metabolic diseases in the whole pregnancy cycle, establish a clinical database and a long-term follow-up bio-bank, and form an early predictive system for the impact of maternal endocrine and metabolic diseases on the metabolism of offspring, so as to provide a scientific basis for comprehensively predicting the short-term and long-term metabolic trajectories of offspring.

Conditions

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Thyroid Dysfunction Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Disease group

No interventions

No interventions assigned to this group

Control group

No interventions

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* Twin or multiple pregnancy
* Severe pregnancy complications
* Complicated with important heart, liver, kidney, blood system and autoimmune diseases before pregnancy
* Associated with other diseases that may affect intestinal flora or metabolomics, including inflammatory bowel disease, irritable bowel syndrome, celiac disease, etc.
* Gastrointestinal and biliary surgeries, including bariatric surgery and cholecystectomy
* History of smoking, alcoholism, narcotic drug use
* For women who keep stool samples: antibiotics within 2 months of specimen collection: probiotics within 1 week of specimen collection: take oral drugs that may affect intestinal flora.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xinhua Xiao

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xinhua Xiao

Role: STUDY_DIRECTOR

Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100730, China

Locations

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Key Laboratory of Endocrinology, Ministry of Health, Department of Endocrinology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, , China

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xinhua Xiao

Role: CONTACT

[email protected]
+86-10-139 1183 0085

Facility Contacts

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Xinhua Xiao

Role: primary

References

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Reference Type BACKGROUND
PMID: 34879977 (View on PubMed)

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Reference Type BACKGROUND
PMID: 10852853 (View on PubMed)

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Reference Type BACKGROUND
PMID: 18070988 (View on PubMed)

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Lv H, Diao F, Du J, Chen T, Meng Q, Ling X, Li H, Song C, Xi Q, Jiang Y, Xu Y, Tao S, Huang L, Wen M, Peng M, Liu C, Lu Q, He Y, Yin Y, Liu X, Xu B, Han X, Zhou K, Jiang T, Zhao Y, Ma H, Jin G, Xia Y, Liu J, Lin Y, Hu Z, Shen H. Assisted reproductive technology and birth defects in a Chinese birth cohort study. Lancet Reg Health West Pac. 2021 Jan 22;7:100090. doi: 10.1016/j.lanwpc.2020.100090. eCollection 2021 Feb.

Reference Type BACKGROUND
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Wang YY, Li Q, Guo Y, Zhou H, Wang QM, Shen HP, Zhang YP, Yan DH, Li S, Chen G, Zhou S, He Y, Yang Y, Peng ZQ, Wang HJ, Ma X. Ambient temperature and the risk of preterm birth: A national birth cohort study in the mainland China. Environ Int. 2020 Sep;142:105851. doi: 10.1016/j.envint.2020.105851. Epub 2020 Jun 22.

Reference Type BACKGROUND
PMID: 32585501 (View on PubMed)

Zhou L, Li S, Zhang Q, Yu M, Xiao X. Maternal Exercise Programs Glucose and Lipid Metabolism and Modulates Hepatic miRNAs in Adult Male Offspring. Front Nutr. 2022 Mar 1;9:853197. doi: 10.3389/fnut.2022.853197. eCollection 2022.

Reference Type BACKGROUND
PMID: 35299765 (View on PubMed)

Liu J, Ding L, Zhai X, Wang D, Xiao C, Hui X, Sun T, Yu M, Zhang Q, Li M, Xiao X. Maternal Dietary Betaine Prevents High-Fat Diet-Induced Metabolic Disorders and Gut Microbiota Alterations in Mouse Dams and Offspring From Young to Adult. Front Microbiol. 2022 Apr 5;13:809642. doi: 10.3389/fmicb.2022.809642. eCollection 2022.

Reference Type BACKGROUND
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Zhang Q, Sun X, Xiao X, Zheng J, Li M, Yu M, Ping F, Wang Z, Qi C, Wang T, Wang X. The effect of maternal chromium status on lipid metabolism in female elderly mice offspring and involved molecular mechanism. Biosci Rep. 2017 Apr 28;37(2):BSR20160362. doi: 10.1042/BSR20160362. Print 2017 Apr 30.

Reference Type BACKGROUND
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Zhou L, Xiao X, Li M, Zhang Q, Yu M, Zheng J, Deng M. Maternal Exercise Improves High-Fat Diet-Induced Metabolic Abnormalities and Gut Microbiota Profiles in Mouse Dams and Offspring. Front Cell Infect Microbiol. 2020 Jun 17;10:292. doi: 10.3389/fcimb.2020.00292. eCollection 2020.

Reference Type BACKGROUND
PMID: 32626663 (View on PubMed)

Other Identifiers

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2022-PUMCH-C-019

Identifier Type: -

Identifier Source: org_study_id