Gestational Diabetes Mellitus (GDM)LEGENDNCT07119177
Long-term Evaluation of Gestational Endocrine & Metabolic Dynamics
An observational study of Gestational Diabetes Mellitus (GDM) and Non-communicable Chronic Diseases, run by Yang ZHANG at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM), Non-communicable Chronic Diseases
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 29 Mar 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Lack of pregnancy-related obstetric follow-up records.
- Inability to cooperate with and complete subsequent scheduled follow-ups.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
YANG ZHANG, Doctor, 008601083575103, emilyzy14@sina.com
About this study
Official title: Long-Term Effects of Gestational Diabetes Mellitus on Postpartum Chronic Non-Communicable Diseases: A Prospective Cohort Study
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:
Read more
- 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.
- Keywords
- Gestational Diabetes Mellitus, Long-term Impact, Non-communicable Chronic Diseases, Prospective Cohort, Predictive Model
- Medical subject headings
- Diabetes, Gestational, Noncommunicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of type 2 diabetes mellitus
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).
Measured: 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:
- 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.
Measured: At 8-17 years postpartum
Prevalence of cardiovascular diseases
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.
Measured: At 8-17 years postpartum
Prevalence of cognitive function
Inquire about history of cognitive function(definitively diagnosed by a qualified physician).
Measured: At 8-17 years postpartum
Prevalence of renal disease
Subjects who meet criterion 1 or 2 will be considered to have renal disease:
- Serum creatinine>133μmol/L.
- Urinary microalbumin/urinary creatinine>30mg/g.
Measured: At 8-17 years postpartum
Secondary outcomes (15)
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
Measured: At 8-17 years postpartum
Thyroid Function
Assessed via measurement of thyroid hormone levels
Measured: At 8-17 years postpartum
Bone Density
Assessed via quantitative ultrasound (QUS) measurement of T-scores and Z-scores at the bilateral distal radius.
Measured: 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
Measured: At 8-17 years old
CAIDE Dementia Risk Score
With CAIDE Dementia Risk Score calculated for individuals without history of cognitive function.
Measured: At 8-17 years postpartum
N-acetyl-β-D-glucosaminidase (NAG)
>12U/L is considered early-stage renal tubule injury.
Measured: 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
Measured: At 8-17 years postpartum
Hyperuricemia
Serum uric acid levels exceed 420 μmol/L.
Measured: At 8-17 years postpartum
Hyperhomocysteinemia
Serum homocysteine >15 μmol/L
Measured: 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
Measured: At 8-17 years postpartum
Body fat percentage:
18%-28% is considered normal.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10-18 years old
Social Anxiety Scale for Children (SASC)
Range: 0-20; Higher scores indicate worse condition; no standardized cutoff.
Measured: 10-18 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start29 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yang ZHANG
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Health Science Center
- Responsible party
- Sponsor-investigator, Yang ZHANG, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119177
- Sponsor's protocol ID
- GDM00120241114
- Other IDs
- 2024IR33
- Acronym
- LEGEND
- Status last verified
- Aug 2025
- First submitted
- 3 Jun 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The clinical information of the participants and the primary outcome data of the LEGEND study will be shared
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effects of Gestational Diabetes Mellitus on Postpartum Chronic Non-Communicable Diseases: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07119177
- Acronym / sponsor ID
- LEGEND / GDM00120241114
- Keywords
- Gestational Diabetes Mellitus, Long-term Impact, Non-communicable Chronic Diseases, Prospective Cohort, Predictive Model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Yang ZHANGUniversity, hospital or other
- Collaborators
- Peking University Health Science Center
- Study start
- 29 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Lack of pregnancy-related obstetric follow-up records.
- Inability to cooperate with and complete subsequent scheduled follow-ups.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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： 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).
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: 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.
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: 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.
Prevalence of cognitive function
Time frame: At 8-17 years postpartum
Inquire about history of cognitive function(definitively diagnosed by a qualified physician).
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: 1. Serum creatinine>133μmol/L. 2. Urinary microalbumin/urinary creatinine>30mg/g.
15 secondary outcomes
Prevalence of anxiety
Time frame: At 8-17 years postpartum
Thyroid Function
Time frame: At 8-17 years postpartum
Bone Density
Time frame: At 8-17 years postpartum
Offspring Growth and Development
Time frame: At 8-17 years old
CAIDE Dementia Risk Score
Time frame: At 8-17 years postpartum
N-acetyl-β-D-glucosaminidase (NAG)
Time frame: At 8-17 years postpartum
Prevalence of depression
Time frame: At 8-17 years postpartum
Hyperuricemia
Time frame: At 8-17 years postpartum
Hyperhomocysteinemia
Time frame: At 8-17 years postpartum
Fatty liver disease
Time frame: At 8-17 years postpartum
Body fat percentage:
Time frame: At 8-17 years postpartum
Kutcher Adolescent Depression Scale (11-item version, KADS-11)
Time frame: 11-17 years old
Swanson, Nolan, and Pelham Rating Scale (SNAP-IV)
Time frame: 10-18 years old
Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time frame: 10-18 years old
Social Anxiety Scale for Children (SASC)
Time frame: 10-18 years old
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Yes. The clinical information of the participants and the primary outcome data of the LEGEND study will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus (GDM) and Non-communicable Chronic Diseases, run by Yang ZHANG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YANG ZHANG, Doctor (008601083575103, emilyzy14@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of type 2 diabetes mellitus (time frame: At 8-17 years postpartum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.