Metabolic and Cardiovascular Complications in Men With Prostate Cancer Undergoing Long-term Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Evaluation for the development of incident diabetes
研究概览
简要总结
The purpose of this study is to examine the link between low testosterone and insulin resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The study will also evaluate other cardiovascular risk factors in these men.
详细描述
Lowering of testosterone levels, by medications or surgery (Androgen Deprivation Therapy or ADT), is commonly used in the treatment of prostate cancer. The adverse effects of low testosterone include decreased sex drive, impotence, decreased lean body mass and muscle strength, increased fat mass, decreased quality of life and osteoporosis.
An increase in body fat and decrease in lean body mass may contribute to a decrease in the body's ability to use insulin effectively, leading to insulin resistance and diabetes. Low testosterone levels are also associated with elevated total cholesterol, LDL-cholesterol and triglycerides.
Two groups of non-diabetic men will be studied:
- Men with known history of prostate cancer who were treated with surgery and/or radiation therapy and are now in remission and not receiving androgen deprivation therapy (non-ADT group).
- Men with newly diagnosed or known history of prostate cancer who are being advised by their physicians to begin androgen deprivation therapy (ADT group).
The non-ADT group and half of the ADT group will be observed for the development of insulin resistance/diabetes. The other half of the ADT group will receive a diabetes medication called Pioglitazone (Actos) to evaluate any beneficial effects of this medication in the prevention of metabolic dysfunction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Men 18 years of age or older with prostate cancer
- •Planning to undergo long-term (at least 12 months) ADT
- •No known history of diabetes
- •No history of ADT
排除标准
- •History of ADT or any prior diagnosis of hypogonadism
- •Fasting glucose or oral glucose tolerance test results in the diabetic range
- •Heart failure (NY classification III or IV)
- •Testosterone level less than 250 ng/dl on screening
- •History of heart attack or open-heart surgery within the past 6 months
- •Use of steroids within the past 3 months, including prednisone, cortisone injections, inhaled steroids (topical steroids are acceptable)
- •Use of anabolic steroids (testosterone, DHEA, DHEAS) or any growth promoters (growth hormone itself or analogs of growth hormone) in the past 12 months
- •Liver function tests more than 3 times upper normal limits
- •Undergoing intermittent ADT
- •Uncontrolled thyroid disease (hyper- or hypo-thyroidism)
- •Anemia, defined as hematocrit less than 38%
- •Not physically capable of completing the tests
研究组 & 干预措施
1
Participants receiving ADT and pioglitazone
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Evaluation for the development of incident diabetes
时间窗: every 3 months
次要结局
- Evaluation for other cardiovascular risk factors, markers of inflammation and immunological changes(every 3 months)