Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics

NCT ID: NCT07119177

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-29
• Study Completion Date: 2026-12-31

Brief Summary

Gestational diabetes mellitus (GDM) is the most common complication and metabolic disorder during pregnancy, with clear risks to both the mother and fetus. In recent years, the long-term chronic diseases and poor prognosis in GDM women after delivery, as well as the risk of obesity and metabolic disorders in their offspring, have become key research topics. However, due to the long duration of GDM's impact on both the mother and offspring and its involvement in multiple disciplines, high-quality cohort studies are scarce. As a result, there is no definitive conclusion regarding the high-risk factors, natural progression, key mediators, timing of interventions, and targets for GDM's long-term effects on mothers and their offspring. This project intends to initiate a prospective follow-up study, establish a specialized cohort for the long-term effects of GDM on both mothers and their offspring, and complete the characterization of the natural course of non-communicable chronic diseases (NCDs) in GDM women and their offspring. The study will also explore high-risk and mediator factors, and develop predictive models. The goal is to provide education, postpartum follow-up, monitoring, and possibly initiate primary prevention for GDM women to reduce the long-term NCD risks, ultimately improving their life expectancy and providing a theoretical basis for intervention.

Inclusion Criteria:

1. Adult patients (≥18 years old) who registered for antenatal care and delivered at Peking University Firest Hospital's obstetrics department between 2007 and 2016.

2. Diagnosed with gestational diabetes mellitus (GDM) during pregnancy via an oral glucose tolerance test (OGTT).

3. Signed informed consent.

Exclusion Criteria:

1. Lack of pregnancy-related obstetric follow-up records.

2. Inability to cooperate with and complete subsequent scheduled follow-ups.

Conditions

Gestational Diabetes Mellitus (GDM); Non-communicable Chronic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥18 years old) who registered for antenatal care and delivered at Peking University Firest Hospital's obstetrics department between 2007 and 2016.
• Diagnosed with gestational diabetes mellitus (GDM) during pregnancy via an oral glucose tolerance test (OGTT).
• Signed informed consent.

Exclusion Criteria

• Lack of pregnancy-related obstetric follow-up records.
• Inability to cooperate with and complete subsequent scheduled follow-ups.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Health Data Science at Peking University

UNKNOWN

Sponsor Role: collaborator

Yang ZHANG

OTHER

Sponsor Role: lead

Responsible Party

Yang ZHANG

Associated chief of the endocrinology department of peking university first hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

YANG ZHANG, Doctor

Role: CONTACT

emilyzy14@sina.com

008601083575103

Facility Contacts

YANG ZHANG, Doctor

Role: primary

emilyzy14@sina.com

008601083575103

Other Identifiers

2024IR33

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GDM00120241114

Identifier Type: -

Identifier Source: org_study_id