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NCT Number: NCT07119177

Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of type 2 diabetes mellitus

    Time frame: At 8-17 years postpartum

    Subjects who meet either criterion 1 or 2 will be considered to have type 2 diabetes:

    • 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%.

    • 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).
  2. Prevalence of metabolic syndrome

    Time frame: At 8-17 years postpartum

    Individuals meeting 3 or more of the following 5 components will be considered to have metabolic syndrome:

    • Waist circumference ≥ 85 cm in women;
    • FPG ≥ 6.1 mmol/L and/or 2hPG ≥ 7.8 mmol/L, and/or previously diagnosed diabetes;
    • Blood pressure ≥ 130/85 mmHg, and/or previously diagnosed hypertension and treated;
    • Fasting TG ≥ 1.7 mmol/L;
    • Fasting HDL-C < 1.04 mmol/L.
  3. Prevalence of cardiovascular diseases

    Time frame: At 8-17 years postpartum

    The presence of any of the following items is considered indicative of cardiovascular disease:

    • Inquire about history(definitively diagnosed by a qualified physician) of cardiovascular diseases, including coronary heart disease, hypertension and arrhythmia.
    • Quantify coronary artery calcium score via non-contrast CT scan, > 100 indicates elevated risk for coronary heart disease.
    • With Framingham Cardiovascular Risk Score calculated for non-diseased individuals(men ≥15 and women ≥18 are classified as high cardiovascular risk).
    • Perform an electrocardiogram for diagnose of arrhythmia.
    • 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.
    • Carotid ultrasonography is performed to assess carotid plaque.
  4. Prevalence of cognitive function

    Time frame: At 8-17 years postpartum

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

  5. Prevalence of renal disease

    Time frame: At 8-17 years postpartum

    Subjects who meet criterion 1 or 2 will be considered to have renal disease:

    • Serum creatinine>133μmol/L.
    • Urinary microalbumin/urinary creatinine>30mg/g.

Secondary outcomes

  1. Prevalence of anxiety

    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

  2. Thyroid Function

    Time frame: At 8-17 years postpartum

    Assessed via measurement of thyroid hormone levels

  3. Bone Density

    Time frame: At 8-17 years postpartum

    Assessed via quantitative ultrasound (QUS) measurement of T-scores and Z-scores at the bilateral distal radius.

  4. Offspring Growth and Development

    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

  5. CAIDE Dementia Risk Score

    Time frame: At 8-17 years postpartum

    With CAIDE Dementia Risk Score calculated for individuals without history of cognitive function.

  6. N-acetyl-β-D-glucosaminidase (NAG)

    Time frame: At 8-17 years postpartum

    >12U/L is considered early-stage renal tubule injury.

  7. Prevalence of depression

    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

  8. Hyperuricemia

    Time frame: At 8-17 years postpartum

    Serum uric acid levels exceed 420 μmol/L.

  9. Hyperhomocysteinemia

    Time frame: At 8-17 years postpartum

    Serum homocysteine >15 μmol/L

  10. Fatty liver disease

    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

  11. Body fat percentage:

    Time frame: At 8-17 years postpartum

    18%-28% is considered normal.

  12. Kutcher Adolescent Depression Scale (11-item version, KADS-11)

    Time frame: 11-17 years old

    Range: 0-33; Higher scores indicate worse status. A total score ≥9 suggests a depressive state.

  13. Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)

    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.

  14. Screen for Child Anxiety Related Emotional Disorders (SCARED)

    Time frame: 10-18 years old

    Range: 0-82; Higher scores indicate worse condition; a total score ≥25 suggests anxiety.

  15. Social Anxiety Scale for Children (SASC)

    Time frame: 10-18 years old

    Range: 0-20; Higher scores indicate worse condition; no standardized cutoff.

Study contacts

Contact information is provided by the study sponsor or research team.

YANG ZHANG, Doctor

CONTACT

[email protected]

008601083575103

Sponsors and collaborators

Lead sponsor

Yang Zhang

Other

Collaborators

  • National Institute of Health Data Science at Peking University

Registry information

Official study title

Long-Term Effects of Gestational Diabetes Mellitus on Postpartum Chronic Non-Communicable Diseases: A Prospective Cohort Study

Acronym: LEGEND

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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