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
Recruitment status was: Not yet recruiting
Sponsor:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01637727
First Posted: July 11, 2012
Last Update Posted: July 13, 2012
Information provided by (Responsible Party):
Shaare Zedek Medical Center
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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 |
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 ]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. ]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 |
|---|
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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.
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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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Eligibility
Information from the National Library of Medicine
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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
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
| Responsible Party: | Shaare Zedek Medical Center |
| ClinicalTrials.gov Identifier: | NCT01637727 History of Changes |
| Other Study ID Numbers: |
GDM.CTIL GDMLTE.10 |
| First Submitted: | June 24, 2012 |
| First Posted: | July 11, 2012 |
| Last Update Posted: | July 13, 2012 |
| Last Verified: | July 2012 |
Keywords provided by Shaare Zedek Medical Center:
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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:
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Diabetes Mellitus Diabetes, Gestational Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Pregnancy Complications |