NCT04539288

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,099

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2018

Completed
2 years until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

5.1 years

First QC Date

September 5, 2018

Last Update Submit

September 3, 2020

Conditions

Gestational Diabetes

Keywords

GDMT2DMNGTlipids

Outcome Measures

Primary Outcomes (1)

  • T2DM

    Women with GDM develop T2DM in postpartum.

    4-6 weeks.

Secondary Outcomes (1)

  • IGT

    4-6 weeks.

Study Arms (1)

Gestational diabetes mellitus

Women who were diagnosed GDM in 24-28 gestation weeks.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

GDM Women.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dongyu Wang, PhD

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2018

First Posted

September 4, 2020

Study Start

May 1, 2013

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

September 7, 2020

Record last verified: 2020-09

Locations

CN(1)