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Clinical Trials/NCT05952739
NCT05952739
Recruiting
Not Applicable

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

Peking Union Medical College Hospital1 site in 1 country300 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyroid Dysfunction
Sponsor
Peking Union Medical College Hospital
Enrollment
300
Locations
1
Primary Endpoint
Gestational diabetes mellitus
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
September 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xinhua Xiao

Chief physician

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Gestational diabetes mellitus

Time Frame: Measure blood glucose up to 28 weeks of pregnancy

Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy

Abnormal metabolism of offspring

Time Frame: 1 year

Abnormal birth weight,blood sugar etc; 300 participants

Thyroid dysfunction during pregnancy

Time Frame: Measure thyroid function up to 28 weeks of pregnancy

Slightly higher TSH or positive TPOAb; 140 participants with thyroid dysfunction during pregnancy

Diabetes mellitus complicating pregnancy

Time Frame: Measure blood glucose up to 28 weeks of pregnancy

Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy

Study Sites (1)

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