Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis (GDM)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 22, 2011 |
| Last Updated Date | November 28, 2011 |
| Start Date ICMJE | March 2007 |
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
|
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01480895 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
|
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis |
| Official Title ICMJE | Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style |
| 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:
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. |
| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Condition ICMJE | Gestational Diabetes Mellitus |
| Intervention ICMJE | 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. |
| Study Arm (s) |
|
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 180 |
| Completion Date | April 2010 |
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Female |
| Ages | 18 Years to 43 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01480895 |
| Other Study ID Numbers ICMJE | SOR452307CTL |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Naomi Meyerstein, Soroka University Medical Center |
| Study Sponsor ICMJE | Soroka University Medical Center |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Soroka University Medical Center |
| Verification Date | November 2011 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|