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

NCT ID: NCT03246295

Last Updated: 2017-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-20

Study Completion Date

2017-10-01

Brief Summary

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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

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Conditions

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Gestational Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gestational diabetes mellitus

Those women were diagnosed as gestational diabetes mellitus

lifestyle intervention or insulin treatment

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

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lifestyle 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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wuxueyan

professor,MD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Duo Y, Song S, Qiao X, Zhang Y, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. A Simplified Screening Model to Predict the Risk of Gestational Diabetes Mellitus in Pregnant Chinese Women. Diabetes Ther. 2023 Dec;14(12):2143-2157. doi: 10.1007/s13300-023-01480-8. Epub 2023 Oct 16.

Reference Type DERIVED
PMID: 37843770 (View on PubMed)

Duo Y, Song S, Zhang Y, Qiao X, Xu J, Zhang J, Peng Z, Chen Y, Nie X, Sun Q, Yang X, Wang A, Sun W, Fu Y, Dong Y, Lu Z, Yuan T, Zhao W. Relationship between serum uric acid in early pregnancy and gestational diabetes mellitus: a prospective cohort study. Endocrine. 2024 Mar;83(3):636-647. doi: 10.1007/s12020-023-03544-y. Epub 2023 Oct 2.

Reference Type DERIVED
PMID: 37782356 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30796299 (View on PubMed)

Other Identifiers

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ZS976

Identifier Type: -

Identifier Source: org_study_id

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