Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women (GDM)
This study is not yet open for participant recruitment.
(see Contacts and Locations)
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
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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 ] [ 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.
|
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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.
|
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637727
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 Endocrine System Diseases |
Glucose Metabolism Disorders Metabolic Diseases Pregnancy Complications |
ClinicalTrials.gov processed this record on March 03, 2015