Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorYang ZHANG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Lack of pregnancy-related obstetric follow-up records.
Inability to cooperate with and complete subsequent scheduled follow-ups.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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).
Time frame
At 8-17 years postpartum2
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.
Time frame
At 8-17 years postpartum3
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.
Time frame
At 8-17 years postpartum4
Prevalence of cognitive function
Inquire about history of cognitive function(definitively diagnosed by a qualified physician).
Time frame
At 8-17 years postpartumSecondary outcomes
1
Prevalence of anxiety
Assessed by standardized depression and anxiety scales \[Zung Self-rating Anxiety Scale(SAS)\]. Anxiety Severity Classification: Normal: \<50, Mild Anxiety: 50-59, Moderate Anxiety: 60-69, Severe Anxiety: ≥70
Time frame
At 8-17 years postpartum2
Thyroid Function
Assessed via measurement of thyroid hormone levels
Time frame
At 8-17 years postpartum3
Bone Density
Assessed via quantitative ultrasound (QUS) measurement of T-scores and Z-scores at the bilateral distal radius.
Time frame
At 8-17 years postpartum4
Offspring Growth and Development
Growth curve values persistently below the 3rd percentile (P3) or above the 97th percentile (P97), as defined by the \*China Height and Weight Percentile Curves for Children and Adolescents Aged 2-18 Years\* developed by the Growth and Development Research Laboratory, Capital Institute of Pediatrics, were considered indicative of abnormal growth
Time frame
At 8-17 years oldSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yang ZHANG
Lead sponsor
Peking University First Hospital
Sponsor institution
National Institute of Health Data Science at Peking University
Collaborator
Source ClinicalTrials.gov