Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes Mellitus (GDM), Non-communicable Chronic Diseases. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-Term Effects of Gestational Diabetes Mellitus on Postpartum Chronic Non-Communicable Diseases: A Prospective Cohort Study
Overview
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.
Primary outcome measures
- Prevalence of type 2 diabetes mellitus [Time frame: At 8-17 years postpartum]
- Prevalence of metabolic syndrome [Time frame: At 8-17 years postpartum]
- Prevalence of cardiovascular diseases [Time frame: At 8-17 years postpartum]
- Prevalence of cognitive function [Time frame: At 8-17 years postpartum]
- Prevalence of renal disease [Time frame: At 8-17 years postpartum]
Secondary outcome measures (12)
- Prevalence of anxiety [Time frame: At 8-17 years postpartum]
- Thyroid Function [Time frame: At 8-17 years postpartum]
- Bone Density [Time frame: At 8-17 years postpartum]
- Offspring Growth and Development [Time frame: At 8-17 years old]
- CAIDE Dementia Risk Score [Time frame: At 8-17 years postpartum]
- N-acetyl-β-D-glucosaminidase (NAG) [Time frame: At 8-17 years postpartum]
- Prevalence of depression [Time frame: At 8-17 years postpartum]
- Hyperuricemia [Time frame: At 8-17 years postpartum]
- Hyperhomocysteinemia [Time frame: At 8-17 years postpartum]
- Fatty liver disease [Time frame: At 8-17 years postpartum]
- Body fat percentage: [Time frame: At 8-17 years postpartum]
- Kutcher Adolescent Depression Scale (11-item version, KADS-11) [Time frame: 11-17 years old]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT07119177 · GDM00120241114 · 2024IR33