Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus

Gestational Diabetes Mellitus Clinical Trial

Official title:

Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus Based on Gestational Metabolic Profile and Lipid Profile

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670548
• Other study ID #: IRB-20220336-R
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Zhaoxia Liang, Prof.
• Phone: 86571-89992115
• Email: xiaozaizai[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (GDM) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. We intend to build an early pregnancy prediction model for postpartum glucose metabolism abnormalities of GDM. At the same time, this project plans to develop a predictive management system based on this model, so that it can be widely used in clinical detection process, realize the advance of the early warning window period of abnormal glucose metabolism, and provide theoretical guidance for the early postpartum blocking of GDM to the outcome of abnormal glucose metabolism.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

Inclusion Criteria:

• Plan to have routine prenatal examinations and give birth in the research center

• GDM was diagnosed at 24-28 gestational weeks

• Singleton pregnancy

• Without other pregnancy complications

• 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, heart disease, liver and kidney diseases, thyroid diseases with drug, 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
• Gestational Diabetes Mellitus

Intervention

Other:
• Questionnaire survey and specimen collection
A questionnaire survey was conducted when pregnant women were enrolled, and blood were collected at 24-28 gestational weeks. Placenta and umbilical cord blood are collected during delivery.

Locations

Country	Name	City	State
China	Women's Hospital School Of Medicine Zhejiang University	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	Serum lipidomics	The differential serum lipid molecules in serum were detected by the self-developed detection chip, and the markers related to postpartum glucose metabolism abnormalities in GDM were screened. Specimens were collected during the 24-28 geatational weeks.	During the 24-28 geatational weeks.
Primary	Serum metabolomics	The differential serum metabolism molecules in serum were detected by the self-developed detection chip, and the markers related to postpartum glucose metabolism abnormalities in GDM were screened. Specimens were collected during the 24-28 geatational weeks.	During the 24-28 geatational weeks.