Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis (GDM)
Primary Purpose
Gestational Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle instruction for Jews and Bedouin GDM women.
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus focused on measuring Diabetes Mellitus Type 2, Gestational Diabetes Mellitus, Glucose Intolerance, Physical exercise, Nutritional Habits, Dyslipidemia
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of gestational diabetes.
Exclusion Criteria:
- Diabetes Mellitus
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Post GDM follow-up group.
lifestyle intervention group.
Arm Description
The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program.
Outcomes
Primary Outcome Measures
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).
Change in HOMA.
HOMA calculations post partum.
Secondary Outcome Measures
Determinations of blood lipids .
Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.
Change in lipids levels after two years post partum.
Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.
Post partum BMI changes.
BMI assessments after one year.
BMI changes after delivery.
BMI assessments after delivery.
Full Information
NCT ID
NCT01480895
First Posted
November 22, 2011
Last Updated
November 28, 2011
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01480895
Brief Title
Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis
Acronym
GDM
Official Title
Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Diabetes Mellitus is a very common chronic metabolic disorder,currently an epidemic with correlation to obesity. DM frequency differs as a function of population characteristics factors. In Israel it is more prevalent in Jews than in Bedouins. However, lately, there has been a rise in DM frequency in the Bedouin population. This rise is probably due to the change in life style from the traditional way of life towards a western one, characterized by change in food habits and decrease in physical activity. This combination may lead to increased body mass index (BMI)and to DM.
Many studies report higher incidence of DM type 2 following Gestational Diabetes Mellitus (GDM). GDM is defined as glucose intolerance which is detected during pregnancy in healthy women. Its frequency varies between 1 to 14% in pregnant women in different populations. Although usually glucose intolerance disappears after delivery,many of these women may develop future GMD or DM type 2. This can be delayed or even prevented by appropriate diet and increased physical activity.
The aim of our study was:
To determine GDM frequency in Jewish and Bedouin populations in the Negev area in southern Israel.
To approach Jewish and Bedouin GDM women before discharge from the hospital and invite them to join the study and divide them into intervention group and control respectively.
To study whether intervention in life style leads to similar results in both populations.
To propose a model for predicting persistent lifestyle change intervention.
The study included 180 women diagnosed with GDM ,133 Jewish and 47 Bedouin women.The women were divided in two groups, an intervention group (77 Jewish and 26 Bedouin) and control ones (56 Jewish and 21 Bedouin women). At their first visit, 3 months after delivery all women filled forms about demographic data, nutrition and physical habits. All of them, including the control group were given full information about GDM and increased risk for DM.
All the women signed their informed consent forms for participation in the study. The intervention group had several group meetings every several months. Metabolic parameters were determined, including plasma insulin ,glucose and lipids levels.Height, weight, BMI, blood pressure and abdominal circumference were measured too. The same parameters were determined one and two years post partum. The intervention group had several group meetings every several months with a dietician and a physical exercise instructor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
Keywords
Diabetes Mellitus Type 2, Gestational Diabetes Mellitus, Glucose Intolerance, Physical exercise, Nutritional Habits, Dyslipidemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Post GDM follow-up group.
Arm Type
No Intervention
Arm Title
lifestyle intervention group.
Arm Type
Experimental
Arm Description
The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle instruction for Jews and Bedouin GDM women.
Other Intervention Name(s)
Jew and Bedouin women with recent GDM in the Negev area.
Intervention Description
Every several months the women had instructions and checkups.
Primary Outcome Measure Information:
Title
Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
Description
The metabolic parameters included glucose and insulin levels, to enable calculations of HOMA IR. (Homeostasis Model Assessment of Insulin Resistance).
Time Frame
Determination of HOMA after one year.
Title
Change in HOMA.
Description
HOMA calculations post partum.
Time Frame
Detrmination of HOMA after two years.
Secondary Outcome Measure Information:
Title
Determinations of blood lipids .
Description
Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.
Time Frame
Post partum lipids levels after one year.
Title
Change in lipids levels after two years post partum.
Description
Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.
Time Frame
2 years after delivery.
Title
Post partum BMI changes.
Description
BMI assessments after one year.
Time Frame
one year after delivery.
Title
BMI changes after delivery.
Description
BMI assessments after delivery.
Time Frame
Two years after delivery.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosis of gestational diabetes.
Exclusion Criteria:
Diabetes Mellitus
12. IPD Sharing Statement
Learn more about this trial
Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis
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