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Clinical Trials/NCT03246295
NCT03246295
Unknown
Not Applicable

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

Peking Union Medical College Hospital0 sites140 target enrollmentOctober 20, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes Mellitus
Sponsor
Peking Union Medical College Hospital
Enrollment
140
Primary Endpoint
Urinary samples were analyzed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2015
End Date
October 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

wuxueyan

professor,MD

Peking Union Medical College Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Urinary samples were analyzed

Time Frame: 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 Outcomes

  • Urinary samples were analyzed(in the third (>32 weeks) trimester of pregnancy)

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