Biomarkers for Early Screening of Gestational Diabetes Mellitus

Sponsor

Women's Hospital School Of Medicine Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05142020

Collaborator

(none)

480

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gestatiaonl Diabetes Mellitus Early Pregnancy

Study Design

Study Type:

Observational

Anticipated Enrollment :

480 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
GDM group Specimen collection and clinical follow-up
Control group Specimen collection and clinical follow-up

Outcome Measures

Primary Outcome Measures

Significantly different metabolites at 8-10 gestational weeks [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.
Significantly different metabolites at 16-18 gestational weeks [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.
Significantly different metabolites at 24-26 gestational weeks [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.
Significantly different metabolites at 32-34 gestational weeks [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.
Significantly different proteins at 8-10 gestational weeks [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.
Significantly different proteins at 16-18 gestational weeks [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.
Significantly different proteins at 24-26 gestational weeks [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.
Significantly different proteins at 32-34 gestational weeks [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Women's Hospital School Of Medicine Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Women's Hospital School Of Medicine Zhejiang University

ClinicalTrials.gov Identifier:

NCT05142020

Other Study ID Numbers:

Early Screening of GDM

First Posted:

Dec 2, 2021

Last Update Posted:

Jan 11, 2022

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes, Gestational

Diabetes Mellitus

Study Results

No Results Posted as of Jan 11, 2022