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

July 17, 2023 updated by: Xinhua Xiao, Peking Union Medical College Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women with metabolic disease before or during pregnancy and control group

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Disease group
No interventions
Control group
No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gestational diabetes mellitus
Time Frame: Measure blood glucose up to 28 weeks of pregnancy
Hyperglycemia during pregnancy
Measure blood glucose up to 28 weeks of pregnancy
Thyroid dysfunction during pregnancy
Time Frame: Measure thyroid function up to 28 weeks of pregnancy
Slightly higher TSH or positive TPOAb
Measure thyroid function up to 28 weeks of pregnancy
Abnormal metabolism of offspring
Time Frame: 1 year
Abnormal birth weight，blood sugar etc
1 year
Diabetes mellitus complicating pregnancy
Time Frame: Measure blood glucose up to 28 weeks of pregnancy
Hyperglycemia during pregnancy
Measure blood glucose up to 28 weeks of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Director: Xinhua Xiao, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

July 4, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-PUMCH-C-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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