NCT00738140已完成2 期
Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.
研究概览
简要总结
The purpose of this study is to discover if intensive lifestyle changes (such as diet and increased physical activity) improve the body's sensitivity to insulin, and therefore help prevent diabetes and other cardiovascular disease, in men receiving GnRH hormone therapy for prostate cancer.
详细描述
- In this study, participants will be divided into two groups. One group will undergo intensive lifestyle changes (Lifestyle Intervention Group) designed by the Diabetes Prevention Group, and the other (Control Group) will follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program.
- All visits will take place at the General Clinical Research Center at the Massachusetts General Hospital.
- At the initial visit, the following will be performed: Bionutrition evaluation; Oral Glucose Tolerance Test (OGTT); additional blood work and; Dual Energy X-Ray Absorptiometry (DXA) Scan.
- After the initial visit, visits will be scheduled at 3, 6 and 12 months after and the above procedures will be repeated.
- Participants will be randomized into one of the two study groups. Lifestyle Intervention Group: The goal for participants assigned to this group are to achieve and maintain a weight loss of at least 7% of initial body weight through a healthy low calorie, low fat diet and to engage in physical activity of moderate intensity. Control Group: participants in this group will receive standard nutrition and exercise recommendations from the Food Guide Pyramid and the National Cholesterol Education Program Step 1 diet to reduce body weight and increase physical activity.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed prostate cancer
- •Current Hormone therapy with GnRH agonist of 3 months or longer
- •Overweight or obese (body mass index of 25kg/m2 or greater)
- •No other conditions that prevent intensive lifestyle intervention
排除标准
- •History of diabetes mellitus requiring drug therapy
- •Hemoglobin Aic of 7% or greater
- •Symptomatic metastatic disease
- •Myocardial infarction within 6 months
- •Treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels
- •Disease progression according to PSA Working Group Criteria
结局指标
主要结局
To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.
时间窗: 1 year
次要结局
- To evaluate the effects of intensive lifestyle modification on other markers of cardiovascular disease risk.(1 year)
研究者
Matthew R. Smith, MD, PhD
Professor of Medicine
Massachusetts General Hospital
研究点 (6)
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