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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2012 by Shaare Zedek Medical Center.
Recruitment status was: Not yet recruiting

Sponsor:

Information provided by (Responsible Party):

Shaare Zedek Medical Center

ClinicalTrials.gov Identifier:

NCT01637727

First received: June 24, 2012

Last updated: July 12, 2012

Last verified: July 2012

History of Changes

Purpose

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.

Condition
Gestational Diabetes Mellitus


Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:

Long term effects of gestational diabetes mellitus in a population of parous women [ Time Frame: 24-32 months ]
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

Secondary Outcome Measures:

Long term effects of gestational diabetes mellitus in a population of parous women [ Time Frame: 24-32 months. ]
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.

Biospecimen Description:

the women will undergo a physical examination which will include measurements of blood pressure, height, weight and waist circumference.Blood samples will be obtained for evaluation of fasting glucose level, HbA1c, lipid profile and kidney functions.


Estimated Enrollment:	324
Study Start Date:	September 2012
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
GDM1 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.
GDM 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.

Eligibility


Ages Eligible for Study:	20 Years to 45 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The proposed research format is: a case control study using a historical cohort of women diagnosed with GDM. 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

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637727

Contacts


Contact: SORINA GRISARO GRANOVSKY, DR	054-4385480	granovs@012.net.il
Contact: ORIT LAMM, MD	02-9934425 ext 02	ADI.LAM@NB013.com

Locations


Israel
Shaare Zedek Medical Center	Not yet recruiting
Jerusalem, Israel
Sub-Investigator: ORIT LAMM, MD

Sponsors and Collaborators

Shaare Zedek Medical Center

Investigators


Principal Investigator:	Arnon Samueloff, Prof	Shaare Zedek Medical Center
Study Chair:	Sorina Grissaro Granovsky, Dr	Shaare Zedek Medical Center

More Information


Responsible Party:	Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:	NCT01637727 History of Changes
Other Study ID Numbers:	GDM.CTIL GDMLTE.10
Study First Received:	June 24, 2012
Last Updated:	July 12, 2012

Keywords provided by Shaare Zedek Medical Center:


Long term effects of gestational diabetes mellitus in a population of parous women Gestational diabetes mellitus- GDM is defined as glucose intolerance diagnosed during pregnancy and not present shortly after birth

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders	Metabolic Diseases Endocrine System Diseases Pregnancy Complications

ClinicalTrials.gov processed this record on June 26, 2017

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