Gestational Diabetes MellitusGDMNCT01637727
Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
An observational study of Gestational Diabetes Mellitus, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- How many people
- 324 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- 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
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-32 months
Secondary outcomes (1)
Long term effects of gestational diabetes mellitus in a population of parous women
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.
Measured: 24-32 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnon Samueloff, Prof, Principal investigator, Shaare Zedek Medical CenterSorina Grissaro Granovsky, Dr, Study chair, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637727
- Sponsor's protocol ID
- GDM.CTIL
- Other IDs
- GDM.CTIL, GDMLTE.10
- Acronym
- GDM
- Status last verified
- Jul 2012
- First submitted
- 24 Jun 2012
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women
- ClinicalTrials.gov ID
- NCT01637727
- Acronym / sponsor ID
- GDM / GDM.CTIL
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (estimated)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- We established the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Long term effects of gestational diabetes mellitus in a population of parous women
Time frame: 24-32 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnon Samueloff, Prof principal investigator
Shaare Zedek Medical Center
Sorina Grissaro Granovsky, Dr study chair
Shaare Zedek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SORINA GRISARO GRANOVSKY, DR (054-4385480, granovs@012.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effects of gestational diabetes mellitus in a population of parous women (time frame: 24-32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.