Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus

Sponsor
Women's Hospital School Of Medicine Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05670548
Collaborator
(none)
2,000
1
36
55.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaire survey and specimen collection

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus Based on Gestational Metabolic Profile and Lipid Profile
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Abnormal postpartum glucose metabolism

GDM with positive OGTT results at 6-12 weeks postpartum

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.

Control

GDM with negative OGTT results at 6-12 weeks postpartum

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Women's Hospital School Of Medicine Zhejiang University Hangzhou Zhejiang China 310006

Sponsors and Collaborators

  • Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Study Director: Zhaoxia Liang, Prof., Women's Hospital School Of Medicine Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier:
NCT05670548
Other Study ID Numbers:
  • IRB-20220336-R
First Posted:
Jan 4, 2023
Last Update Posted:
Jan 4, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 4, 2023