NCT07263412
Recruiting
Not Applicable
A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
The First Affiliated Hospital with Nanjing Medical University1 site in 1 country1,000 target enrollmentStarted: February 25, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Improvement Rate of Glucose Metabolism During the Perinatal Period
Overview
Brief Summary
A Multicenter Prospective Cohort Study to Identify Risk Factors and Develop a Diagnostic Prediction Model for Gestational Diabetes Mellitus, and to Evaluate the Effectiveness of Multidisciplinary Precision Health Interventions (GLOW Plan)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All must be met
- •Aged 18-40 years;
- •Pre-pregnancy BMI: 18.5 kg/m² \< BMI \< 28 kg/m²;
- •Able to read, understand and sign the informed consent form;
- •Receive prenatal care and deliver in the study hospital.
Exclusion Criteria
- •Any one met leads to exclusion
- •Twin or multiple pregnancies;
- •Pre-gestational diabetes mellitus (PGDM), including new-onset diabetes during pregnancy;
- •Poorly controlled pre-pregnancy chronic hypertension (BP ≥140/90 mmHg);
- •Complicated with severe liver/kidney diseases;
- •Current/recent use of drugs affecting glucose metabolism;
- •Mental illness or severe psychological disorders;
- •Complicated with severe infection;
- •Poor compliance or refusal to use CGM/SMBG.
Outcomes
Primary Outcomes
Improvement Rate of Glucose Metabolism During the Perinatal Period
Time Frame: From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum.
Secondary Outcomes
- Improvement Rate of Glucose Metabolism in GDM Pregnant Women After Intervention(From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum)
- Long-term Incidence of Cardiovascular Disease (CVD)(From 6 months postpartum to 2 years postpartum)
- Long-term Incidence of Type 2 Diabetes Mellitus (T2DM)(From 6 months postpartum to 2 years postpartum)
- Incidence of Adverse Outcomes(From participant enrollment (23-24+6 weeks of gestation) to 6 weeks postpartum)
- Abnormal Blood Glucose Status in Offspring(From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth))
- Obesity Rate in Offspring(From 6 months postpartum (6 months after offspring's birth) to 2 years postpartum (2 years after offspring's birth))
Investigators
Study Sites (1)
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