Biomarkers for Early Screening of Gestational Diabetes Mellitus

December 21, 2021 updated by: Women's Hospital School Of Medicine Zhejiang University

Study on Early Screening Biomarkers of Gestational Diabetes Mellitus and Its Related Pathogenesis

Gestational Diabetes Mellitus (GDM) refers to the abnormal glucose metabolism first detected during pregnancy. It is estimated that approximately 7% of pregnant women worldwide and their offspring are affected by GDM. The incidence of GDM in China is as high as 18.9%. A number of studies have shown that GDM complicates 3%-25% of pregnancies and poses serious health and life threats to the mother and child. In fact, due to the lack of physical activity during pregnancy and the decrease of insulin sensitivity compared with non-pregnancy, the optimal time for intervention has long been lost until the diagnosis of GDM in the second trimester. However, it is a pity that no authoritative screening method for GDM in early pregnancy has been established, and the pathogenesis of GDM is still unclear. This study intend to search for biomarkers used for screening of GDM in early pregnancy and explore the pathogenesis of GDM, so as to provide new ideas for prevention measures and treatment targets of GDM.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

20 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.

Description

Inclusion Criteria:

  • Maternal age: 20-49 years
  • Plan to have routine prenatal examinations and give birth in the research center
  • Willing to cooperate with the hospital to follow up

Exclusion Criteria:

  • Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, AIDS, etc.
  • Fetus has a known deformity or genetic defects
  • Incomplete clinical data

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
GDM group
Specimen collection and clinical follow-up
Control group
Specimen collection and clinical follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significantly different metabolites at 8-10 gestational weeks
Time Frame: Gestatioanl weeks: 8-10 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 8-10 weeks
Significantly different metabolites at 16-18 gestational weeks
Time Frame: Gestatioanl weeks: 16-18 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 16-18 weeks
Significantly different metabolites at 24-26 gestational weeks
Time Frame: Gestatioanl weeks: 24-26 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 24-26 weeks
Significantly different metabolites at 32-34 gestational weeks
Time Frame: Gestatioanl weeks: 32-34 weeks
Metabolomics are used to screen out significant different metabolites. Specific metabolites indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 32-34 weeks
Significantly different proteins at 8-10 gestational weeks
Time Frame: Gestatioanl weeks: 8-10 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 8-10 weeks
Significantly different proteins at 16-18 gestational weeks
Time Frame: Gestatioanl weeks: 16-18 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 16-18 weeks
Significantly different proteins at 24-26 gestational weeks
Time Frame: Gestatioanl weeks: 24-26 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 24-26 weeks
Significantly different proteins at 32-34 gestational weeks
Time Frame: Gestatioanl weeks: 32-34 weeks
Proteomics are used to screen out significant different proteins. Specific proteins indicators will be given based on the results of preliminary experiments. The changes of biomarkers are observed at different gestational weeks.
Gestatioanl weeks: 32-34 weeks

Collaborators and Investigators

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

Sponsor

Women's Hospital School Of Medicine Zhejiang University

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 (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 21, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Early Screening of GDM

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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