Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics

Not yet recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT06753734
• Lead Sponsor: Tianjin Central Hospital of Gynecology Obstetrics

Brief Summary

This study aim to develope novel breath markers of gestational diabetes through a prospective high-risk population cohort study and achieve early prediction of gestational diabetes based on an interpretable machine learning model.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Last Update Submitted: 2024-12-23
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Primary Completion: 2026-03
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• 18-55 years old, 11-14 weeks of pregnancy, at least one risk factor for GDM, signed a written informed consent

Exclusion Criteria

• Diabetes mellitus or abnormal glucose metabolism before pregnancy; Hyperemesis gravidarum (urine ketone positive)); Thyroid dysfunction; Asthmatic patients;Hypertensive diseases that are difficult to control;Severe hepatic and renal insufficiency or severe electrolyte disturbance; Malignant tumor;Acute inflammation;lung disease; Patients with gastritis, duodenum and other digestive system diseases;Those with upper respiratory or oral problems who cannot cooperate with expiratory collection;smoker

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of gestational diabetes mellitus	24-28 weeks gestation