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

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ClinicalTrials.gov Identifier: NCT01637727
Recruitment Status : Unknown
Verified July 2012 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2012
Last Update Posted : July 13, 2012
Sponsor:
Information provided by (Responsible Party):
Shaare Zedek Medical Center

Study Description
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Brief 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.

Condition or disease
Gestational Diabetes Mellitus

Study Design
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Study Type : Observational
Estimated Enrollment : 324 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
Study Start Date : September 2012
Estimated Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01637727     History of Changes
Other Study ID Numbers: GDM.CTIL
GDM.CTIL
GDMLTE.10
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 13, 2012
Last Verified: July 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