Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
NCT Number: NCT07119177
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At 8-17 years postpartum
Subjects who meet either criterion 1 or 2 will be considered to have type 2 diabetes:
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%.
Time frame: At 8-17 years postpartum
Individuals meeting 3 or more of the following 5 components will be considered to have metabolic syndrome:
Time frame: At 8-17 years postpartum
The presence of any of the following items is considered indicative of cardiovascular disease:
Time frame: At 8-17 years postpartum
Inquire about history of cognitive function(definitively diagnosed by a qualified physician).
Time frame: At 8-17 years postpartum
Subjects who meet criterion 1 or 2 will be considered to have renal disease:
Time frame: At 8-17 years postpartum
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 postpartum
Assessed via measurement of thyroid hormone levels
Time frame: At 8-17 years postpartum
Assessed via quantitative ultrasound (QUS) measurement of T-scores and Z-scores at the bilateral distal radius.
Time frame: At 8-17 years old
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 postpartum
With CAIDE Dementia Risk Score calculated for individuals without history of cognitive function.
Time frame: At 8-17 years postpartum
>12U/L is considered early-stage renal tubule injury.
Time frame: At 8-17 years postpartum
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
Time frame: At 8-17 years postpartum
Serum uric acid levels exceed 420 μmol/L.
Time frame: At 8-17 years postpartum
Serum homocysteine >15 μmol/L
Time frame: At 8-17 years postpartum
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
Time frame: At 8-17 years postpartum
18%-28% is considered normal.
Time frame: 11-17 years old
Range: 0-33; Higher scores indicate worse status. A total score ≥9 suggests a depressive state.
Time frame: 10-18 years old
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.
Time frame: 10-18 years old
Range: 0-82; Higher scores indicate worse condition; a total score ≥25 suggests anxiety.
Time frame: 10-18 years old
Range: 0-20; Higher scores indicate worse condition; no standardized cutoff.
Contact information is provided by the study sponsor or research team.
Yang Zhang
Other
Long-Term Effects of Gestational Diabetes Mellitus on Postpartum Chronic Non-Communicable Diseases: A Prospective Cohort Study
Acronym: LEGEND
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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