Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women

Gestational Diabetes Mellitus Clinical Trial

— GDM  

Official title:

Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01637727
• Other study ID #: GDM.CTIL
• Secondary ID: GDM.CTILGDMLTE.1
• Status: Not yet recruiting
• Phase: N/A
• First received: June 24, 2012
• Last updated: July 12, 2012
• Start date: September 2012

Study information

• Verified date: July 2012
• Source: Shaare Zedek Medical Center
• Contact: SORINA GRISARO GRANOVSKY, DR
• Phone: 054-4385480
• Email: granovs[@]012.net.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The primary goal of this proposed research deals with estimating the risk of developing type 2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a history of GDM. In addition, this study will attempt to evaluate the effect of parity on the late appearance of type 2 diabetes and metabolic syndrome in this unique population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 324
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010.

• Women with a GDM history will be identified based on the gestational diabetes clinic files.

• Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records

Exclusion Criteria:

• We established the following exclusion criteria:

• women who are diagnosed with metabolic syndrome before pregnancy or have type 1 or type 2 diabetes, and

• women with severe chronic diseases.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term effects of gestational diabetes mellitus in a population of parous women	The primary goal of this proposed research deals with estimating the risk of developing type 2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a history of GDM	24-32 months	Yes
Secondary	Long term effects of gestational diabetes mellitus in a population of parous women	In addition, this study will attempt to evaluate the effect of parity on the late appearance of type 2 diabetes and metabolic syndrome in this unique population.	24-32 months.	Yes