Clinical Trial

Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics

Study acronym: LEGEND
Recruiting
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07119177
Lead Sponsor Yang ZHANG
Collaborators: Peking University Health Science Center
Conditions Gestational Diabetes Mellitus (GDM), Non-communicable Chronic Diseases
Enrollment 800 participants
Start Date 2025-03-29
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-12