Clinical trial NCT05952739: Maternal Endocrine System and Metabolic Diseases and Offspring Health: Prediction Within a Birth Cohort
Official title: Maternal Endocrine System and Metabolic Diseases and Offspring Health: Prediction Within a Birth Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Dysfunction
Diabetes Mellitus
Keywords: Hyperglycemia during pregnancy
Thyroid Dysfunction During Pregnancy
Offspring metabolic diseases
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with metabolic disease before or during pregnancy and control group

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.

Eligibility criteria: lnclusion Criteria:

* Pregnant women
* Voluntary signing of informed consent

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.

Primary outcomes:
measure: Gestational diabetes mellitus
timeFrame: Measure blood glucose up to 28 weeks of pregnancy
measure: Thyroid dysfunction during pregnancy
timeFrame: Measure thyroid function up to 28 weeks of pregnancy
measure: Abnormal metabolism of offspring
timeFrame: 1 year
measure: Diabetes mellitus complicating pregnancy
timeFrame: Measure blood glucose up to 28 weeks of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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
Study officials:
affiliation: 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
name: Xinhua Xiao
role: STUDY_DIRECTOR
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