Biomarkers for Early Screening of Gestational Diabetes Mellitus

N/AUnknownNCT05142020

Women's Hospital School Of Medicine Zhejiang University480 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

480

Conditions

Gestatiaonl Diabetes Mellitus Early Pregnancy

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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.

Time frame: Gestatioanl weeks: 8-10 weeks

Significantly different metabolites at 16-18 gestational weeks

Time frame: Gestatioanl weeks: 16-18 weeks

Significantly different metabolites at 24-26 gestational weeks

Time frame: Gestatioanl weeks: 24-26 weeks

Significantly different metabolites at 32-34 gestational weeks

Time frame: Gestatioanl weeks: 32-34 weeks

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.