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Biomarkers for Early Screening of Gestational Diabetes Mellitus

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05142020
Enrollment
480
Registered
2021-12-02
Start date
2022-01-01
Completion date
2023-12-31
Last updated
2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Pregnancy, Gestatiaonl Diabetes Mellitus

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.

Interventions

None listed

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 49 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Significantly different metabolites at 8-10 gestational weeksGestatioanl weeks: 8-10 weeksMetabolomics 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 weeksGestatioanl weeks: 16-18 weeksMetabolomics 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 weeksGestatioanl weeks: 24-26 weeksMetabolomics 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 weeksGestatioanl weeks: 32-34 weeksMetabolomics 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 weeksGestatioanl weeks: 8-10 weeksProteomics 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 weeksGestatioanl weeks: 16-18 weeksProteomics 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 weeksGestatioanl weeks: 24-26 weeksProteomics 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 weeksGestatioanl weeks: 32-34 weeksProteomics 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026