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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

Tracking Information
First Submitted Date June 24, 2012
First Posted Date July 11, 2012
Last Update Posted Date July 13, 2012
Study Start Date September 2012
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 10, 2012)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 12, 2012)
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.
Original Secondary Outcome Measures
 (submitted: July 10, 2012)
  • 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.
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
Official Title Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen 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.
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
Condition Gestational Diabetes Mellitus
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 10, 2012)
324
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01637727
Other Study ID Numbers GDM.CTIL
GDM.CTIL
GDMLTE.10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shaare Zedek Medical Center
Study Sponsor Shaare Zedek Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Arnon Samueloff, Prof Shaare Zedek Medical Center
Study Chair: Sorina Grissaro Granovsky, Dr Shaare Zedek Medical Center
PRS Account Shaare Zedek Medical Center
Verification Date July 2012