Serum Biomarkers Associated With Postpartum T2DM in Women... | NCT04539288

Studies
Serum Biomarkers Associated With Postpartum T2DM in Women With GDM

NCT04539288

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Status

Completed

Last Update Posted

Sep 7, 2020Actual

Enrollment

3,099Actual

Phase

Not provided

Conditions

Gestational Diabetes

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2013Actual

Primary Completion Date

May 30, 2018Actual

Completion Date

May 30, 2018Actual

First Submitted Date

Sep 5, 2018

First Submission Date that Met QC Criteria

Sep 1, 2020

First Posted Date

Sep 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2020

Last Update Posted Date

Sep 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dongyu Wang, Principal Investigator, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital, Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,099Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gestational diabetes mellitus		Women who were diagnosed GDM in 24-28 gestation weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Other	There is no intervention in this study.	Gestational diabetes mellitus

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

GDM Women.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dongyu Wang, PhD	First Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University		Guangzhou	Guangdong	510080	China

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided