Biomarkers for Early Screening of Gestational Diabetes Mellitus

Early Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05142020
• Other study ID #: Early Screening of GDM
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Early Pregnancy

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