NCT01077479已完成2 期
Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks
研究概览
简要总结
The main purpose of this study is to assess the efficacy of metformin in abrogating androgen deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model assessment (HOMAIR) in men with non-metastatic prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •≥ 18 years of age
- •Histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only (≤ 5 sites of bone metastases only)
- •Plan to receive ≥ 6 months continuous androgen deprivation therapy by a GnRH agonist
- •Patients who are to receive antiandrogens with GnRH agonists are not excluded from the study. But the form, dose and duration of antiandrogen treatment should be recorded.
- •Adequate renal function (Creatinine ≤ 177mMol/L and GFR >30 mls/min )
- •Adequate hepatic function (Bilirubin must be ≤ 1.5 x upper limit of normal range, ALT and ALP must be ≤ 2.5 x upper limit of normal)
排除标准
- •Visceral involvement
- •> 5 sites of bone metastases
- •History of confirmed diabetes mellitus (patients with impaired fasting glucose or impaired glucose intolerance will not be excluded) 12
- •Treatment with medications that may alter glucose or insulin level within 3 months (including insulin, oral hypoglycemic agents, systemic corticosteroid of any dosage, atypical antipsychotic drugs of any dose)
- •Malignant disease other than prostate cancer at the time of enrolment
- •Bilateral orchiectomy
- •Previous androgen deprivation therapy by a GnRH agonist or anti-androgen within last 12 months(patient who had a GnRH agonist more than 12 months ago are allowed if their testosterone levels are in the normal range at the time of recruitment)
- •Chemotherapy within 6 months
- •History of lactic acidosis
- •Cardiac or respiratory insufficiency, severe infection that is likely to increase the risk of lactic acidosis
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent
研究组 & 干预措施
Metformin
Experimental
干预措施: Metformin (Drug)
结局指标
主要结局
The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks
时间窗: 12 and 24 weeks
次要结局
- To assess the efficacy of metformin in abrogating ADT-induced insulin resistance as measured by whole-body insulin sensitivity index(ISI) at 3 and 6 months(12 and 24 weeks)
- To assess the efficacy of metformin in reducing the incidence of ADT-induced metabolic syndrome at 3 and 6 months(12 and 24 weeks)
- To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months(24 weeks)
- To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months(12 and 24 weeks)
- To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants(24 weeks)
研究者
Howard Gurney
A/Prof Howard Gurney
Western Sydney Local Health District
研究点 (1)
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