CClinicalTrials.gg
Status unknownNCT03246295Updated Aug 11, 2017

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

An observational study in Gestational Diabetes Mellitus, sponsored by Peking Union Medical College Hospital. Status unknown. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2017-08-11.

Sponsored by Peking Union Medical College Hospital · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Gestational Diabetes Mellitus

Keywords

  • Proteomics
  • Metabolomics
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In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 140 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

Pregnant women were recruited in early pregnancy, and followed up to 6 weeks postpartum

Inclusion criteria

-Pregnant women (\<12 weeks)

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Gestational diabetes mellitus

    Those women were diagnosed as gestational diabetes mellitus

    Other: lifestyle intervention or insulin treatment

  • Control

    Those women were diagnosed without gestational diabetes mellitus

Interventions

  • Otherlifestyle intervention or insulin treatment

    Firstly,the gestational diabetes mellitus(GDM) women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled.

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What researchers measure

Primary outcomes

  1. Urinary samples were analyzed

    Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.

    Time frame: in the first (<12 weeks) trimester of pregnancy

Secondary outcomes

  1. Urinary samples were analyzed

    Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.

    Time frame: in the second (24-28 weeks) trimester of pregnancy

  2. Urinary samples were analyzed

    Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.

    Time frame: in the third (>32 weeks) trimester of pregnancy

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Liu X, Wang X, Sun H, Guo Z, Liu X, Yuan T, Fu Y, Tang X, Li J, Sun W, Zhao W. Urinary metabolic variation analysis during pregnancy and application in Gestational Diabetes Mellitus and spontaneous abortion biomarker discovery. Sci Rep. 2019 Feb 22;9(1):2605. doi: 10.1038/s41598-019-39259-2. Erratum In: Sci Rep. 2019 Nov 26;9(1):18003. doi: 10.1038/s41598-019-54733-7. PubMed 30796299 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03246295
Lead sponsor
Peking Union Medical College Hospital
Responsible party
wuxueyan (professor,MD, Peking Union Medical College Hospital) — Principal investigator
First posted
Aug 11, 2017
Start date
Oct 20, 2015
Primary completion
Sep 1, 2017 (estimated)
Completion
Oct 1, 2017 (estimated)
Last update
Aug 11, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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