Biomarkers for Early Screening of Gestational Diabetes Mellitus

NCT05142020 | Unknown

• 1 other identifier: Early Screening of GDM
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestatiaonl Diabetes Mellitus; Early Pregnancy

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

GDM group

Specimen collection and clinical follow-up

Control group

Specimen collection and clinical follow-up

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Danqing Chen

Hangzhou, Zhejiang, 310006, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, serum, urine, tissue (placenta and umbilical cord)

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: December 2, 2021
• Study Start: January 1, 2022
• Primary Completion: August 22, 2022
• Study Completion: December 31, 2023
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

CN (1)