Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus

Recruiting

• Conditions: Gestational Diabetes Mellitus
• Interventions: Other: Questionnaire survey and specimen collection

• Registration Number: NCT05670548
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-01
• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-01
• Last Update Submitted: 2023-01-01
• Study First Posted: 2023-01-04
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abnormal postpartum glucose metabolism	Questionnaire survey and specimen collection	GDM with positive OGTT results at 6-12 weeks postpartum
Control	Questionnaire survey and specimen collection	GDM with negative OGTT results at 6-12 weeks postpartum

Primary Outcome Measures

Name	Time	Method
Serum lipidomics	During the 24-28 geatational weeks.	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.
Serum metabolomics	During the 24-28 geatational weeks.	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.

Trial Locations

Locations (1)

Women's Hospital School Of Medicine Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China