Identification of Gestational Diabetes Mellitus Related Urinary Biomarkers Along Pregnancy (From Early Pregnancy to Postpartum) by Using Proteomics and Metabolomics Analysis

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: lifestyle intervention or insulin treatment

• Registration Number: NCT03246295
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Gestational diabetes mellitus (GDM) has many adverse effects on pregnant women and fetuses. At present, no prediction marker for GDM in early pregnancy is accepted. There is still a lack of recognized early predictors. This study was designed to identity valuable biomarkers for GDM.This was a prospective observed cohort study. 140 pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum. Glucose challenge test and 75g oral glucose tolerance test were performed after 24 weeks of pregnancy, and GDM was diagnosed according to the latest ADA standard. Urinary samples were collected in the first (\<12 weeks), second (24\~28 weeks) and third (32\~weeks) trimester of pregnancy. Urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry. 15 cases of GDM women and 50 cases of control women were used for longitudinal analysis; 15 cases of GDM women and 15 cases of age matched control women were used for difference analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-20
• Study First Submitted: 2017-07-23
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-07
• Last Update Submitted: 2017-08-07
• Study First Posted: 2017-08-11
• Last Update Posted: 2017-08-11
• Primary Completion: 2017-09-01
• Study Completion: 2017-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

-Pregnant women （<12 weeks）

Exclusion Criteria

• with renal dysfunction
• urine routine examination abnormalities for twice
• history of urinary and reproductive system diseases
• with other chronic diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gestational diabetes mellitus	lifestyle intervention or insulin treatment	Those women were diagnosed as gestational diabetes mellitus

Primary Outcome Measures

Name	Time	Method
Urinary samples were analyzed	in the first (<12 weeks) trimester of pregnancy	Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.

Secondary Outcome Measures

Name	Time	Method
Urinary samples were analyzed	in the third (>32 weeks) trimester of pregnancy	Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.