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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
GDM group
Specimen collection and clinical follow-up
Control group
Specimen collection and clinical follow-up

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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