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临床试验/NCT00680797
NCT00680797已完成不适用

Metabolic Effects of Androgenicity in Aging Men and Women

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2005年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
33
试验地点
1
主要终点
Insulin Sensitivity

研究概览

简要总结

The goal of this research study is to study the effect of testosterone or estrogen on blood sugar control and fat metabolism. Changes in hormone levels with age may affect risk factors for heart disease such as diabetes. Diabetes is a glandular condition associated with lack of the hormone insulin or an insensitivity to it resulting in problems with blood sugar control and fat metabolism. The effect of commonly used hormonal supplements such as testosterone by older adults on insulin and body composition is not well understood. In this study, the role of testosterone and estrogen on your ability to control blood sugar and your body composition will be assessed.

The investigators plan to study 60 subjects. All of these subjects will be healthy older men between the ages of 60-85 years old who are not on testosterone therapy. Subjects that are screened who have any clinically significant abnormalities detected on their screening physical exam or laboratory testing (e.g. Prostate Specific Antigen > 4), who have a history of prostate cancer, polycythemia, or who cannot take testosterone will not be included.

If a subject is eligible to participate after initial screening, that subject will take medications to adjust their hormone levels and have tests performed that measure insulin sensitivity and adiposity before and after these hormone medications. The outcomes that will be measured are: 1) insulin sensitivity, 2) hormone levels (total and free testosterone levels, sex hormone-binding globulin levels) and 3) body composition and abdominal adiposity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • males age 60-85 years
  • non-diabetic fasting glucose and 2-hour oral glucose tolerance test (OGTT)
  • overall good general medical health and signed informed consent
  • willing to travel to West Los Angeles VA and University of California, Los Angeles in Los Angeles, California

排除标准

  • any clinically significant abnormalities detected on screening physical exam or laboratory testing (e.g. prostate specific antigen > 4)
  • or other symptom or history of a significant underlying medical or psychiatric illness
  • BMI < 20 or > 40
  • subjects already on testosterone therapy or medications that might influence glucose regulation or hormone levels
  • subjects with a history of deep venous thromboses, pulmonary embolism, breast cancer, prostate cancer, polycythemia or other contraindications to estrogen or testosterone

研究组 & 干预措施

-T +E

Experimental

-Testosterone, +Estrogen

干预措施: Estrogen (Drug)

+T +E

Experimental

+Testosterone, +Estrogen

干预措施: Testosterone (Drug)

+T +E

Experimental

+Testosterone, +Estrogen

干预措施: Estrogen (Drug)

+T -E

Experimental

+Testosterone, -Estrogen

干预措施: Testosterone (Drug)

结局指标

主要结局

Insulin Sensitivity

时间窗: 6 weeks

As measured by change in insulin levels pre- and post-hormone changes

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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