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| ID | Type | Description | Link |
|---|---|---|---|
| 2024IR33 | Other Grant/Funding Number | Peking university first hospital |
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| Name | Class |
|---|---|
| National Institute of Health Data Science at Peking University | UNKNOWN |
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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:
Exclusion Criteria:
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of type 2 diabetes mellitus | Subjects who meet either criterion 1 or 2 will be considered to have type 2 diabetes：
| 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:
| At 8-17 years postpartum |
| Prevalence of cardiovascular diseases | The presence of any of the following items is considered indicative of cardiovascular disease:
| At 8-17 years postpartum |
| Prevalence of cognitive function |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 8-17 years postpartum |
| Thyroid Function |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YANG ZHANG, Doctor | Contact | 008601083575103 | emilyzy14@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
The clinical information of the participants and the primary outcome data of the LEGEND study will be shared
IPD will be available half year after the last participants finished the study
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D000073296 | Noncommunicable Diseases |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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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:
| At 8-17 years postpartum |
Assessed via measurement of thyroid hormone levels |
| At 8-17 years postpartum |
| Bone Density | Assessed via quantitative ultrasound (QUS) measurement of T-scores and Z-scores at the bilateral distal radius. | At 8-17 years postpartum |
| 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 | At 8-17 years old |
| CAIDE Dementia Risk Score | With CAIDE Dementia Risk Score calculated for individuals without history of cognitive function. | At 8-17 years postpartum |
| N-acetyl-β-D-glucosaminidase (NAG) | >12U/L is considered early-stage renal tubule injury. | At 8-17 years postpartum |
| Prevalence of depression | Assessed by standardized depression and anxiety scales [Zung Self-Rating Depression Scale(SDS)]. Depression Severity Classification: Normal: <53, Mild Depression: 53-62, Moderate Depression: 63-72, Severe Depression: ≥73 | At 8-17 years postpartum |
| Hyperuricemia | Serum uric acid levels exceed 420 μmol/L. | At 8-17 years postpartum |
| Hyperhomocysteinemia | Serum homocysteine >15 μmol/L | At 8-17 years postpartum |
| Fatty liver disease | Liver Transient Elastography (CAP) Fat Attenuation Grading: Normal: <244 dB/m Mild Hepatic Steatosis: 244-269 dB/m Moderate Hepatic Steatosis: 269-296 dB/m Severe Hepatic Steatosis: >296 dB/m | At 8-17 years postpartum |
| Body fat percentage: | 18%-28% is considered normal. | At 8-17 years postpartum |
| Kutcher Adolescent Depression Scale (11-item version, KADS-11) | Range: 0-33; Higher scores indicate worse status. A total score ≥9 suggests a depressive state. | 11-17 years old |
| Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) | Items 1-9 constitute the Attention Deficit subscale (range: 0-27, ≤13: Normal); Items 10-18 constitute the Hyperactivity-Impulsivity subscale (range: 0-27, ≤13: Normal); Items 19-26 constitute the Oppositional Defiant subscale: Abnormality is defined as ≥4 items scored as 2 or 3. | 10-18 years old |
| Screen for Child Anxiety Related Emotional Disorders (SCARED) | Range: 0-82; Higher scores indicate worse condition; a total score ≥25 suggests anxiety. | 10-18 years old |
| Social Anxiety Scale for Children (SASC) | Range: 0-20; Higher scores indicate worse condition; no standardized cutoff. | 10-18 years old |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |