Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus
• Intervention / Treatment: Other: Questionnaire survey and specimen collection

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Zhaoxia Liang, Prof.; Phone Number: 86571-89992115; Email: xiaozaizai@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Women's Hospital School of Medicine Zhejiang University
      • Contact: Zhaoxia Liang, Prof.; Phone Number: 86571-89992115; Email: xiaozaizai@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This project intends to recruit pregnant women with GDM who go to the research center for routine prenatal examination and OGTT screening at 24-28 gestational weeks.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: January 1, 2023
• First Submitted That Met QC Criteria: January 1, 2023
• First Posted (Estimate): January 4, 2023

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 1, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: IRB-20220336-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No