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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
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 43 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    November 22, 2011
    Last Updated
    November 28, 2011
    Sponsor
    Soroka University Medical Center
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    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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