睾酮和营养补充对营养不良老年人的影响
2006年9月7日 更新者:University of Adelaide
单独和联合使用睾酮和营养补充剂对老年人营养不良的不良影响
本研究的目的是确定单独和联合使用睾酮和营养补充剂治疗一年对社区老年男性和女性营养不良的不利影响有何影响。
研究概览
详细说明
我们假设口服雄激素疗法和营养补充剂将对生活在社区中的老年营养不良个体产生额外的有益影响;随着功能测量的改善和瘦体重的增加,住院、跌倒和体重减轻的情况将会减少。
本研究旨在检验 12 个月口服营养补充剂和雄激素治疗(单独和联合)对 (i) 住院频率和时间的影响; (ii) 功能状态; (iii) 身体成分和体重; (iv) 生活安排; (v) 死亡率,在社区居住的 65 岁及以上的营养不良男性和女性中。
研究类型
介入性
注册
200
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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South Australia
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Adelaide、South Australia、澳大利亚、5000
- Royal Adelaide Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 及以上 (OLDER_ADULT)
接受健康志愿者
不
有资格学习的性别
全部
描述
纳入标准:
- 营养不良的 65 岁或以上的男性和女性,定义为迷你营养评估 (MNA) 评分 <24 且满足以下 1 项或以上:*体重指数 (BMI) 低于 22 kg/m2 ; *参加研究前 3 个月体重减轻 > 7.5%
- 在社区独立生活(不在医院、疗养院或旅馆)
- 理解并签署知情同意书,能够与研究者沟通,理解并遵守研究要求。
- 服用雌激素或其他激素替代疗法 (HRT) 的女性可以参加(请参阅例外情况的排除标准),不服用 HRT 的女性也可以参加。 如果一位女性正在服用 HRT,她必须在参加研究前至少服用稳定剂量 3 个月。 如果不接受 HRT,她在注册前至少 3 个月内不得服用。
排除标准:
- Folstein 的简易精神状态检查 (MMSE) 分数 < 23 表明患有痴呆症
- 血细胞比容 (HCT) 水平升高 (>50%)
- 男性前列腺癌的过去或现在病史(前列腺特异性抗原 (PSA) 水平 [> 年龄相关的正常范围和/或前列腺检查不规则的前列腺])或乳腺癌。
- 受试者或研究者关注的女性预先存在的雄激素体征或症状(低沉的声音、多毛症、痤疮、雄激素性脱发)。
- 抑郁症(Yesavage 老年抑郁量表 (GDS) 评分 > 11)
- 无法参加 DEXA 扫描或完成研究的其他要求
- 严重心力衰竭(NYHA III 级及以上)
- 肝功能检查明显异常(ALT、GGT、胆红素或 ALP 超过正常上限的 2 倍)
- 肾病综合征; 24 小时尿蛋白排泄 > 3 克(如果基线尿液分析显示 > 1+ 蛋白尿,将进行量化)和/或计算肌酐清除率(通过 Baracskay 和 Jarjoura 等式计算门诊老年受试者 [Cr 清除率 = 4.4/血清肌酐(mmol /L) + (88-age)](63) < 30 ml/min) 和/或血清肌酐浓度 > 0.2mmol/l。
- 截肢者(体重指数、肌酐清除率和身体成分估计不准确)。
- 研究者认为可能在一年内导致死亡的任何疾病
- 在开始研究前的四个月内接受睾酮或其他雄激素治疗(包括 DHEA 和替勃龙)。
- 服用环孢菌素或巴比妥类药物
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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在医院的日子
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SF-36 生活质量评分(综合身体成分评分和综合心理成分评分)。
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次要结果测量
结果测量 |
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死亡
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身体构成
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肌肉力量
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跌倒次数
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功能状态(生活安排、日常生活活动和虚弱量表评分)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年7月1日
研究完成
2007年2月1日
研究注册日期
首次提交
2005年6月30日
首先提交符合 QC 标准的
2005年6月30日
首次发布 (估计)
2005年7月1日
研究记录更新
最后更新发布 (估计)
2006年9月11日
上次提交的符合 QC 标准的更新
2006年9月7日
最后验证
2006年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
十一酸睾酮的临床试验
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Memorial Sloan Kettering Cancer Center招聘中