Serum Biomarkers Associated With Postpartum T2DM in Women With GDM

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539288
• Other study ID #: 50102013
• Status: Completed
• Start date: May 1, 2013
• Est. completion date: May 30, 2018

Study information

• Verified date: September 2020
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3099
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Locations

Country	Name	City	State
China	Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	T2DM	Women with GDM develop T2DM in postpartum.	4-6 weeks.
Secondary	IGT	Women with GDM were impaired glucose intolerance in postpartum.	4-6 weeks.