Clinical trial NCT01480895: Prevention of Diabetes Mellitus Type 2 in Women Post Gestational Diabetes Mellitus Diagnosis
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
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Diabetes Mellitus Type 2
Gestational Diabetes Mellitus
Glucose Intolerance
Physical exercise
Nutritional Habits
Dyslipidemia
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of gestational diabetes.

Exclusion Criteria:

* Diabetes Mellitus

Primary outcomes:
measure: Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
timeFrame: Determination of HOMA after one year.
measure: Change in HOMA.
timeFrame: Detrmination of HOMA after two years.
Secondary outcomes:
measure: Determinations of blood lipids .
timeFrame: Post partum lipids levels after one year.
measure: Change in lipids levels after two years post partum.
timeFrame: 2 years after delivery.
measure: Post partum BMI changes.
timeFrame: one year after delivery.
measure: BMI changes after delivery.
timeFrame: Two years after delivery.
Other outcomes:
Locations:
Study officials:
References: