- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246295
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
Status
Unknown
Conditions
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZS976
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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