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:
Shaare Zedek Medical Center
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 24, 2012 | ||||||||
| Last Updated Date | July 12, 2012 | ||||||||
| Start Date ICMJE | September 2012 | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01637727 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women | ||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| 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. |
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| 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 |
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| Condition ICMJE | Gestational Diabetes Mellitus | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 324 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 20 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01637727 | ||||||||
| Other Study ID Numbers ICMJE | GDM.CTIL, GDM.CTIL, GDMLTE.10 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Shaare Zedek Medical Center | ||||||||
| Study Sponsor ICMJE | Shaare Zedek Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Shaare Zedek Medical Center | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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