Insulin Resistance in Men With Prostate Cancer on Androgen Deprivation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- insulin sensitivity
研究概览
简要总结
Prostate cancer is the most common malignancy amongst men in United States. Androgen deprivation therapy (ADT) with long acting gonadotropin releasing hormone agonists is routinely used as adjuvant therapy in intermediate and high risk localized or locally advanced prostate cancer. Since ADT induces insulin resistance and diabetes, it is important that cellular and molecular effects of ADT are investigated to define precisely the mechanisms involved in the pathogenesis of insulin resistance. Pioglitazone, a known insulin sensitizer, may provide amelioration of insulin resistance in these patients.
详细描述
Investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled trial in 44 men with nonmetastatic prostate cancer who are receiving ADT with long acting GnRH agonist (study group). Study subjects will undergo insulin clamp, subcutaneous fat biopsy, muscle biopsy, have a blood sample taken and fibroscan performed prior to randomization of study drug. They will then be randomized to 30 mg pioglitazone or placebo tablet daily for 6 months. Blood samples will be drawn 2 and 4 months following the initiation of the study drug. The final study visit will be at 6 months. Subjects will undergo clamp, fat biopsy, muscle biopsy, blood sampling, fibroscan and will be discharged from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer, non-metastatic
- •Have been on ADT with long acting GnRH agonist continuously for last 3 months, AND planning to continue ADT for at least 6 months
排除标准
- •Used pioglitazone in last 6 months
- •Heart Failure NYHA Class 3 or 4
- •Known to have osteoporosis at this time.
- •history of bladder cancer
- •Hemoglobin <8 g/dl
- •eGFR <15 ml/min/1.73m2
- •liver enzymes (ALT or AST) >3 times the upper limit of normal
研究组 & 干预措施
Pioglitazone
干预措施: Pioglitazone 30 mg (Drug)
placebo
干预措施: placebo tablet (Drug)
结局指标
主要结局
insulin sensitivity
时间窗: 6 months
The primary endpoint of the study is to detect a difference in insulin sensitivity as measured by whole body glucose uptake during clamps after treatment with pioglitazone as compared to placebo.
次要结局
- Insulin signaling (Insulin receptor substrate expression in fat tissue)(6 months)
研究者
Sandeep Singh Dhindsa, M.D., F.A.C.E
Professor of Medicine
St. Louis University