Evaluation on Prevention for Metabolic Syndrome and Diabetes Mellitus Through Lifestyle Modification Intervention in Prediabetic Subjects
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- blood sugar
研究概览
简要总结
The lifestyle intervention program focusing on healthy dietary habit and exercise effectively prevents progression to diabetes. Thus, the purpose of this study was to assess the effectiveness of lifestyle intervention program on pre-diabetics subjects in Taiwan.
详细描述
The study is a 2-parallel groups' randomized controlled trial. Participants with elevated fasting plasma glucose concentrations (FPG 100-125 mg/dl) or glycated hemoglobin (HbA1C 5.7-6.3%) are enrolled. All study subjects are randomized to receive a lifestyle intervention (intervention group) or regular prevention education (control group). The parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and each follow visit (3th months, 6th months and 12th months). All participants complete a structured questionnaire, including basic information, disease history, physical activity, food-frequency, stage of change, and social support situation.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 years old or over
- •elevated fasting plasma glucose concentrations (FPG: 100-125 mg/dl) or glycated hemoglobin(HbA1C: 5.7-6.3%)
排除标准
- •having received a diagnosis of diabetes or receiving treatment for diabetes in 3 years
- •having a history of cardiovascular disease, stroke, liver disease, kidney disease, cardiopulmonary disease, malignancy or cancer and musculoskeletal impairment
- •receiving corticosteroids, androgens, estrogen containing compounds
- •who had dietary problem
- •pregnant women
- •who joined other health intervention study in one year.
结局指标
主要结局
blood sugar
时间窗: 3 month, 6 month and 12-month follow up
changes in fasting glucose and glycated hemoglobin
次要结局
- body weight(3 month, 6 month and 12-month follow up)
- BMI(3 month, 6 month and 12-month follow up)
- Metabolic syndrome(3 month, 6 month and 12-month follow up)