Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis
GDM
Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style
1 other identifier
interventional
180
0 countries
N/A
Brief Summary
Diabetes Mellitus (DM) is a chronic metabolic disorder with increasing incidence and long term complications. Its incidence differs in various ethnic populations.Gestational DM (GDM) is diagnosed when impaired glucose tolerance (IGT) is first detected during pregnancy. GDM incidence in Jewish and Bedouin women has been rising in recent years. It has been reported in many studies that women who had been diagnosed with GDM are more prone to GDM in their next pregnancies and to DM Type 2. Appropriate changes in everyday diet and physical exercise may reduce the chances for future GDM and type 2 DM. The investigators aim was to determine GDM frequency in the Negev area in Jewish and Bedouin populations and to construct a plan for follow up and reduce future problems by changing their life style.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2007
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
November 22, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedNovember 29, 2011
November 1, 2011
3 years
November 22, 2011
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
The metabolic parameters included glucose and insulin levels, to enable calculations of HOMA IR. (Homeostasis Model Assessment of Insulin Resistance).
Determination of HOMA after one year.
Change in HOMA.
HOMA calculations post partum.
Detrmination of HOMA after two years.
Secondary Outcomes (4)
Determinations of blood lipids .
Post partum lipids levels after one year.
Change in lipids levels after two years post partum.
2 years after delivery.
Post partum BMI changes.
one year after delivery.
BMI changes after delivery.
Two years after delivery.
Study Arms (2)
Post GDM follow-up group.
NO INTERVENTIONlifestyle intervention group.
EXPERIMENTALThe women in this group had participated in lifestyle intervention by diet instructions and physical exercise program.
Interventions
Every several months the women had instructions and checkups.
Eligibility Criteria
You may qualify if:
- Diagnosis of gestational diabetes.
You may not qualify if:
- Diabetes Mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Naomi Meyerstein M D
Study Record Dates
First Submitted
November 22, 2011
First Posted
November 29, 2011
Study Start
March 1, 2007
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
November 29, 2011
Record last verified: 2011-11