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

August 7, 2017 updated by: wuxueyan, Peking Union Medical College Hospital
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gestational diabetes mellitus
Those women were diagnosed as gestational diabetes mellitus
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.
Control
Those women were diagnosed without gestational diabetes mellitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
in the first (<12 weeks) trimester of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary samples were analyzed
Time Frame: in the second (24-28 weeks) trimester of pregnancy
Urinary samples were collected and urinary proteomics and metabolomics were analyzed by ultra-performance liquid chromatography tandem mass spectrometry.
in the second (24-28 weeks) trimester of pregnancy
Urinary samples were analyzed
Time Frame: 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.
in the third (>32 weeks) trimester of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

July 23, 2017

First Submitted That Met QC Criteria

August 7, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 7, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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