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Clinical Trials/NCT05142020
NCT05142020
Active, not recruiting
Not Applicable

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

Women's Hospital School Of Medicine Zhejiang University1 site in 1 country480 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestatiaonl Diabetes Mellitus
Sponsor
Women's Hospital School Of Medicine Zhejiang University
Enrollment
480
Locations
1
Primary Endpoint
Significantly different metabolites at 16-18 gestational weeks
Status
Active, not recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

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.

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.

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.

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.

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.

Study Sites (1)

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