NCT05670548

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 1, 2023

Last Update Submit

January 1, 2023

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

Abnormal postpartum glucose metabolism

GDM with positive OGTT results at 6-12 weeks postpartum

Other: Questionnaire survey and specimen collection

Control

GDM with negative OGTT results at 6-12 weeks postpartum

Other: Questionnaire survey and specimen collection

Interventions

Questionnaire survey and specimen collectionOTHER

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.

Abnormal postpartum glucose metabolismControl

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

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, 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, placenta, umbilical cord blood

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Zhaoxia Liang, Prof.

    Women's Hospital School Of Medicine Zhejiang University

    STUDY DIRECTOR

Central Study Contacts

Zhaoxia Liang, Prof.

CONTACT

86571-89992115xiaozaizai@zju.edu.cn

Study Design

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

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 4, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2025

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

CN(1)