Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics

NCT07119177 | Recruiting

• 2 other identifiers: GDM001202411142024IR33
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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. 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. 2.Diagnosed with gestational diabetes mellitus (GDM) during pregnancy via an oral glucose tolerance test (OGTT).
3. 3.Signed informed consent.
4. 4.Lack of pregnancy-related obstetric follow-up records.
5. 5.Inability to cooperate with and complete subsequent scheduled follow-ups.

Conditions

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

Keywords

Gestational Diabetes Mellitus; Long-term Impact; Non-communicable Chronic Diseases; Prospective Cohort; Predictive Model

Outcome Measures

Primary Outcomes (5)

• Prevalence of type 2 diabetes mellitus

  Subjects who meet either criterion 1 or 2 will be considered to have type 2 diabetes： 1. With classical symptoms of diabetes: if any one of the following is met: Random plasma glucose ≥ 11.1 mmol/L, or Fasting plasma glucose (FPG) ≥ 7.0 mmol/L, or 2-hour plasma glucose during an oral glucose tolerance test (OGTT) ≥ 11.1 mmol/L, or HbA1c (glycated hemoglobin) ≥ 6.5%. 2. Without classical symptoms of diabetes: either two glucose indicators measured at the same time point reaching or exceeding diagnostic thresholds, or Glucose indicators measured at two different time points reaching or exceeding diagnostic thresholds (excluding random plasma glucose).

  At 8-17 years postpartum

• Prevalence of metabolic syndrome

  Individuals meeting 3 or more of the following 5 components will be considered to have metabolic syndrome: 1. Waist circumference ≥ 85 cm in women; 2. FPG ≥ 6.1 mmol/L and/or 2hPG ≥ 7.8 mmol/L, and/or previously diagnosed diabetes; 3. Blood pressure ≥ 130/85 mmHg, and/or previously diagnosed hypertension and treated; 4. Fasting TG ≥ 1.7 mmol/L; 5. Fasting HDL-C \< 1.04 mmol/L.

  At 8-17 years postpartum

• Prevalence of cardiovascular diseases

  The presence of any of the following items is considered indicative of cardiovascular disease: 1. Inquire about history(definitively diagnosed by a qualified physician) of cardiovascular diseases, including coronary heart disease, hypertension and arrhythmia. 2. Quantify coronary artery calcium score via non-contrast CT scan, \> 100 indicates elevated risk for coronary heart disease. 3. With Framingham Cardiovascular Risk Score calculated for non-diseased individuals(men ≥15 and women ≥18 are classified as high cardiovascular risk). 4. Perform an electrocardiogram for diagnose of arrhythmia. 5. ABI, TBI, and baPWV are utilized to assess arteriosclerosis in the extremities, ABI \< 0.9 or TBI \< 0.7 or baPWV \> 1400 cm/s is diagnostic of peripheral arterial disease. 6. Carotid ultrasonography is performed to assess carotid plaque.

  At 8-17 years postpartum

• Prevalence of cognitive function

  Inquire about history of cognitive function(definitively diagnosed by a qualified physician).

  At 8-17 years postpartum

• Prevalence of renal disease

  Subjects who meet criterion 1 or 2 will be considered to have renal disease: 1. Serum creatinine\>133μmol/L. 2. Urinary microalbumin/urinary creatinine\>30mg/g.

  At 8-17 years postpartum

Secondary Outcomes (15)

• Prevalence of anxiety

  At 8-17 years postpartum

• Thyroid Function

  At 8-17 years postpartum

• Bone Density

  At 8-17 years postpartum

• Offspring Growth and Development

  At 8-17 years old

• CAIDE Dementia Risk Score

  At 8-17 years postpartum

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Gestational diabetes mellitus (GDM) patients who delivered at Peking University First Hospital between 2007 and 2016 will be identified through electronic medical record searches. We intend to enroll a total of 800 GDM patients meeting the above inclusion/exclusion criteria and their offspring.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yang ZHANG: lead
• National Institute of Health Data Science at Peking University: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

YANG ZHANG, Doctor

CONTACT

008601083575103; emilyzy14@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated chief of the endocrinology department of peking university first hospital

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: August 12, 2025
• Study Start: March 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: IPD will be available half year after the last participants finished the study

Locations

CN (1)