NCT01637727

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.

Trial Health

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Trial Health Score

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Enrollment
324

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

July 13, 2012

Status Verified

July 1, 2012

Enrollment Period

3 years

First QC Date

June 24, 2012

Last Update Submit

July 12, 2012

Conditions

Gestational Diabetes Mellitus

Keywords

Long term effects of gestational diabetes mellitus in a population of parous womenGestational diabetes mellitus- GDM is defined as glucose intolerance diagnosed during pregnancy and not present shortly after birth

Outcome Measures

Primary Outcomes (1)

  • 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

    24-32 months

Secondary Outcomes (1)

  • Long term effects of gestational diabetes mellitus in a population of parous women

    24-32 months.

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • women who are diagnosed with metabolic syndrome before pregnancy or have type 1 or type 2 diabetes, and
  • women with severe chronic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel, Israel

Location

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.

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Arnon Samueloff, Prof

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

  • Sorina Grissaro Granovsky, Dr

    Shaare Zedek Medical Center

    STUDY CHAIR

Central Study Contacts

SORINA GRISARO GRANOVSKY, DR

CONTACT

054-4385480granovs@012.net.il

ORIT LAMM, MD

CONTACT

02-9934425ADI.LAM@NB013.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2012

First Posted

July 11, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Last Updated

July 13, 2012

Record last verified: 2012-07

Locations

IL(1)