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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05142020
Other study ID # Early Screening of GDM
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2023

Study information

Verified date January 2023
Source Women's Hospital School Of Medicine Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 480
Est. completion date December 31, 2023
Est. primary completion date August 22, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 49 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Danqing Chen HangZhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Significantly different metabolites at 8-10 gestational 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
Primary Significantly different metabolites at 16-18 gestational 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
Primary Significantly different metabolites at 24-26 gestational 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
Primary Significantly different metabolites at 32-34 gestational 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
Primary Significantly different proteins at 8-10 gestational 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
Primary Significantly different proteins at 16-18 gestational 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
Primary Significantly different proteins at 24-26 gestational 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
Primary Significantly different proteins at 32-34 gestational 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
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