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

A Cohort Study in Women at High Risk for Gestational Diabetes Based on Breath Metabolomics

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06753734

Enrollment

600

Registered

2024-12-31

Start date

2024-12-25

Completion date

2027-12-31

Last updated

2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Incidence of gestational diabetes mellitus	24-28 weeks gestation

Countries

China

Outcome results