Testosterone Replacement Therapy in Chronic Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)
研究概览
简要总结
It has long been recognized that co-morbidity associated with multiple metabolic syndrome, such as adverse body composition, insulin resistance and autonomic nervous system impairment, may lead to significant increase in cardiovascular morbidity and mortality. It is unclear whether the co-morbidity evident in this population are due directly to their immobility or are the result of unfavorable changes in their underlying hormonal milieu. The purpose of this study is to determine the effect of testosterone replacement therapy in hypogonadal males on:
body composition, i.e. lean tissue and fat mass, glucose tolerance, resting energy expenditure, autonomic-cardiovascular integrity, muscular strength, psychological assessment
详细描述
This study is 24 months in duration. Men who have consented to pre-screening serum testosterone draw and are found to have total testosterone levels averaging ≤ 11.3 nmol/l will start testosterone replacement therapy after a 6-month baseline period. Once treatment begins subjects will place a testosterone replacement patch (5 or 10 mg/day) on various sites of the body daily. Subjects will visit the lab after 2,6, 12, and 18 months of therapy for testing; however they will stop taking the patch at the 12 month visit. If needed, a steroid cream will be provided to the subjects should any skin irritations occur. If the patch causes persistent skin irritations, despite use of the steroid cream, then a testosterone gel may be used. Detailed instructions and precautions using the gel are outlined in the consent form and will be reviewed with the subject.
Those men who have consented to pre-screening serum testosterone and are found to have normal levels of total testosterone (testosterone total ≥ 11.4 nmol/l) are eligible to participate as a control subject for the full 24-month period of the study. These subjects visit the lab at baseline (BL), 12 and 24 months for the same testing as those in the treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males 18-49 years of age
- •Chronic spinal cord injury
- •Normal prostate specific antigen levels and digital rectal exam
- •No known cardiovascular disease
- •Subjects with total testosterone > 4 ng/ml
- •Subjects with total testosterone > 4 ng/ml
排除标准
- •Known coronary heart and/or artery disease, diabetes mellitus
- •Previous or current cancer
- •Current or previous anabolic steroid use
- •Acute inter-current illness
- •Abnormal liver function test (>1.5 times normal values) at baseline
- •Prostate specific antigen above normal
- •Abnormal digital rectal exam at baseline suggestive of malignancy
- •Current alcohol or drug abuse
- •Significant psychological disorders
研究组 & 干预措施
Testosterone Replacement Therapy
Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
干预措施: Testosterone Transdermal System (Androderm 5 mg patch) (Drug)
结局指标
主要结局
Dual Energy X-ray Absorptiometry (DXA) Assessment of Lean Tissue Mass (LTM)
时间窗: 12 months
Dual energy X-ray absorptiometry assessment of lean tissue mass (LTM) at 12 months. Total body scans were performed and the energy level used for each total body scan was based on subject thickness (e. g., thin, standard, or thick). To analyze the results of each total body scan, proprietary software algorithms were used to segment the body into trunk, pelvis, and upper and lower extremities using the standard regions of interest. In accordance with International Society for Clinical Densitometry guidelines, total body scans were repeated on 30 spinal cord injury subjects by the "on-and-off -the-table" method (i. e., subjects were repositioned between scans) and our precision error was equal to 1.2 % for LTM.
次要结局
- Resting Energy Expenditure(12 months)