Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis (GDM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naomi Meyerstein, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01480895
First received: November 22, 2011
Last updated: November 28, 2011
Last verified: November 2011

November 22, 2011
November 28, 2011
March 2007
March 2010   (final data collection date for primary outcome measure)
  • Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance). [ Time Frame: Determination of HOMA after one year. ] [ Designated as safety issue: No ]
    The metabolic parameters included glucose and insulin levels, to enable calculations of HOMA IR. (Homeostasis Model Assessment of Insulin Resistance).
  • Change in HOMA. [ Time Frame: Detrmination of HOMA after two years. ] [ Designated as safety issue: No ]
    HOMA calculations post partum.
Same as current
Complete list of historical versions of study NCT01480895 on ClinicalTrials.gov Archive Site
  • Determinations of blood lipids . [ Time Frame: Post partum lipids levels after one year. ] [ Designated as safety issue: No ]
    Determinations of total lipids , total cholesterol , HDL, LDL and triglycerides levels.
  • Change in lipids levels after two years post partum. [ Time Frame: 2 years after delivery. ] [ Designated as safety issue: No ]
    Determinations of total cholesterol, HDL,LDL,and triglycerides after one year.
  • Post partum BMI changes. [ Time Frame: one year after delivery. ] [ Designated as safety issue: No ]
    BMI assessments after one year.
  • BMI changes after delivery. [ Time Frame: Two years after delivery. ] [ Designated as safety issue: No ]
    BMI assessments after delivery.
Same as current
Not Provided
Not Provided
 
Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis
Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style

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.

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:

  1. To determine GDM frequency in Jewish and Bedouin populations in the Negev area in southern Israel.
  2. 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.
  3. To study whether intervention in life style leads to similar results in both populations.
  4. 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Gestational Diabetes Mellitus
Behavioral: Lifestyle instruction for Jews and Bedouin GDM women.
Every several months the women had instructions and checkups.
Other Name: Jew and Bedouin women with recent GDM in the Negev area.
  • No Intervention: Post GDM follow-up group.
    Intervention: Behavioral: Lifestyle instruction for Jews and Bedouin GDM women.
  • Experimental: lifestyle intervention group.
    The women in this group had participated in lifestyle intervention by diet instructions and physical exercise program.
    Intervention: Behavioral: Lifestyle instruction for Jews and Bedouin GDM women.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
April 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of gestational diabetes.

Exclusion Criteria:

  • Diabetes Mellitus
Female
18 Years to 43 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01480895
SOR452307CTL
Yes
Naomi Meyerstein, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Not Provided
Soroka University Medical Center
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP