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

This study is not yet open for participant recruitment.
Verified July 2012 by Shaare Zedek Medical Center
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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
Genders 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
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

No publications provided

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

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 18, 2013