Serum Biomarkers Associated With Postpartum T2DM in Women With GDM

September 3, 2020 updated by: Dongyu Wang, First Affiliated Hospital, Sun Yat-Sen University

Pregnancy to Postpartum Transition of Serum Biomarkers in Women With Gestational Diabetes

Gestational diabetes mellitus (GDM) is commonly linked to the development of type 2 diabetes mellitus (T2DM). There is a need to characterize metabolic changes associated with GDM in order to find novel biomarkers for T2DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

GDM, a common complication of pregnancy, affects 17.8% of pregnancies worldwide per year. Women with a history of GDM have an approximately 7-fold higher risk for developing T2DM in the future than women without GDM. However, data on the factors associated with the development of T2DM in women with GDM are not widely available.

Study Type

Observational

Enrollment (Actual)

3099

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

GDM Women.

Description

Inclusion Criteria:

  • Women who were dignosed GDM.
  • Women with singleton pregnancy.
  • Give birth in the First Affiliated Hospital in Sun Yat-sen University.

Exclusion Criteria:

  • Women who were diagnosed PGDM.
  • Younger than 18 years old.
  • Older than 45 years old.
  • Multiple pregnancy.
  • Diagnosed DM before.
  • Complicationg other diseases, like hypertension, thyroid diseases, etc.
  • Taking any drug affect glucose and lipid metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gestational diabetes mellitus
Women who were diagnosed GDM in 24-28 gestation weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T2DM
Time Frame: 4-6 weeks.
Women with GDM develop T2DM in postpartum.
4-6 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGT
Time Frame: 4-6 weeks.
Women with GDM were impaired glucose intolerance in postpartum.
4-6 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Dongyu Wang, PhD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

May 30, 2018

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 1, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50102013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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