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

NCT06753734 | Enrolling By Invitation

• 1 other identifier: 2024KY081
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Incidence of gestational diabetes mellitus

  24-28 weeks gestation

Study Arms (2)

Gestational Diabetes Group

control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population in this study include pregnant women aged 18-55 years and at 11-14 weeks gestation with at least one risk factor for GDM

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Central Hospital of Gynecology Obstetrics: lead

Study Sites (1)

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, China

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: December 25, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2024-12

Locations

CN (1)