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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

June 24, 2012
July 12, 2012
September 2012
September 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01637727 on ClinicalTrials.gov Archive Site
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.
  • 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.
  • 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
Not Provided
Not Provided
 
Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
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. 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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
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.
Non-Probability Sample
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
Gestational Diabetes Mellitus
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
324
Not Provided
September 2015   (final data collection date for primary outcome measure)

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.
Female
20 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01637727
GDM.CTIL, GDM.CTIL, GDMLTE.10
No
Not Provided
Not Provided
Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Principal Investigator: Arnon Samueloff, Prof Shaare Zedek Medical Center
Study Chair: Sorina Grissaro Granovsky, Dr Shaare Zedek Medical Center
Shaare Zedek Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP