NCT00455624已完成不适用
Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- insulin sensitity
研究概览
简要总结
The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.
详细描述
- This is a non-treatment study. This study has no effect on the care the participant will receive.
- In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adenocarcinoma of the prostate, clinical stage M0
- •About to initiate GnRH agonist therapy
- •Karnofsky Performance Status 90 or 100
- •Serum creatinine < 2.0mg/dl
排除标准
- •Hormone therapy within 12 months
- •History of diabetes mellitus or glucose intolerance
- •Anabolic agents or metabolic agents known to affect insulin or glucose levels
- •Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)
结局指标
主要结局
insulin sensitity
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Matthew R. Smith, MD, PhD
Professor of Medicine
Massachusetts General Hospital
研究点 (2)
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