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临床试验/NCT05952739
NCT05952739招募中不适用

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

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Gestational diabetes mellitus

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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.

结局指标

主要结局

Gestational diabetes mellitus

时间窗: Measure blood glucose up to 28 weeks of pregnancy

Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy

Abnormal metabolism of offspring

时间窗: 1 year

Abnormal birth weight,blood sugar etc; 300 participants

Thyroid dysfunction during pregnancy

时间窗: 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

时间窗: Measure blood glucose up to 28 weeks of pregnancy

Hyperglycemia during pregnancy; 50 participants with hyperglycemia during pregnancy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinhua Xiao

Chief physician

Peking Union Medical College Hospital

研究点 (1)

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