NCT03246295

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

July 23, 2017

Last Update Submit

August 7, 2017

Conditions

Gestational Diabetes Mellitus

Keywords

ProteomicsMetabolomics

Outcome Measures

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.

    in the first (<12 weeks) trimester of pregnancy

Secondary Outcomes (2)

  • Urinary samples were analyzed

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

  • Urinary samples were analyzed

    in the third (>32 weeks) trimester of pregnancy

Study Arms (2)

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

lifestyle intervention or insulin treatmentOTHER

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.

Gestational diabetes mellitus

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Pregnant women （\<12 weeks）

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 37843770DERIVED

  • 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.

    PMID: 37782356DERIVED

  • 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.

    PMID: 30796299DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary samples

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor，MD

Study Record Dates

First Submitted

July 23, 2017

First Posted

August 11, 2017

Study Start

October 20, 2015

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

August 11, 2017

Record last verified: 2017-08