Identification of Risk Factors for DM Type 2 in Women Post GDM Diagnosis and Its Prevention by Changing Life Style
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 主要终点
- Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of gestational diabetes.
排除标准
- •Diabetes Mellitus
结局指标
主要结局
Change in HOMA ratios (Homeostasis Model Assessments of Insulin Resistance).
时间窗: Determination of HOMA after one year.
The metabolic parameters included glucose and insulin levels, to enable calculations of HOMA IR. (Homeostasis Model Assessment of Insulin Resistance).
Change in HOMA.
时间窗: Detrmination of HOMA after two years.
HOMA calculations post partum.
次要结局
- Post partum BMI changes.(one year after delivery.)
- Determinations of blood lipids .(Post partum lipids levels after one year.)
- BMI changes after delivery.(Two years after delivery.)
- Change in lipids levels after two years post partum.(2 years after delivery.)
研究者
Naomi Meyerstein
Dr Naomi Meyerstein M D
Soroka University Medical Center