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

Tianjin Central Hospital of Gynecology Obstetrics

Status: Invitation-only

Conditions: Gestational Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT06753734

2024KY081

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility 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

Trial design

600 participants in 2 patient groups

Gestational Diabetes Group

control group