NCT00932672终止2 期
Randomized Controlled Clinical Trial of Carbohydrate Restriction Among Men Initiating Androgen Deprivation Therapy For Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 6
- 主要终点
- The primary end-point will be differences in insulin sensitivity between the arms
研究概览
简要总结
This study will test the hypothesis that a low-carbohydrate Atkins diet will prevent or at least minimize the metabolic consequences of androgen deprivation therapy (ADT).
详细描述
Androgen deprivation therapy (ADT) is the standard treatment for advanced prostate cancer. While a very effective anti-cancer treatment, ADT is associated with significant toxicity including but not limited to major metabolic disturbances including impaired glucose tolerance, insulin resistance, and weight gain. We hypothesize that limiting carbohydrates within the diet will prevent or at least minimize these consequences.
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 adenocarcinoma of the prostate
- •Scheduled to initiate ADT with an anticipated duration of ≥ 6 months
- •Overweight or obese (body mass index ≥ 25 kg/m2)
排除标准
- •Symptomatic metastatic disease
- •Myocardial infarction within 6 months
- •Treatment with medications known to affect insulin or glucose levels (i.e. insulin, oral hypoglycemics, prednisone, etc.)
- •Patient consuming a low-carbohydrate diet
- •Medical conditions or co-morbidities that preclude participation in the protocol
- •Vegetarians
结局指标
主要结局
The primary end-point will be differences in insulin sensitivity between the arms
时间窗: 6 months
次要结局
- Measures will include other cardiac risk factors, overall body morphometrics, body composition as assessed by dual energy x-ray absorptiometry (DXA), and cancer control (PSA levels)(6 months)
研究者
研究点 (6)
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