Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Cognitive functions- Processing Speed
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).
详细描述
GHD is the most common anterior pituitary abnormality after traumatic brain injury (TBI). It can occur as a result of either direct pituitary or indirect hypothalamic injury. Sports-related repetitive head trauma might induce pituitary dysfunction, and in particular, isolated GHD. Growth hormone replacement therapy (GHRT) has long been known to have a beneficial effect on body composition and exercise capacity. However, it has recently been shown that GHRT also benefits the brain. The primary objective of the current study is to assess the effect of GH on memory, executive function and attention domains of cognitive function in GHD- professional football players with TBI. The study will also utilize the adult growth hormone deficiency assessment (AGHDA) questionnaire, quantitative electroencephalogram (QEEG) and magnetic resonance imaging (MRI) techniques, respectively, to measure the quality of life (QoL), electrical activity and structural changes in the brain that may correspond to cognitive deficits.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
3-D printing used to design matching cases (covers) for both the drug and placebo autoinjector pens
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study.
- •Former NFL player
- •At least one year since retirement from football
- •Less than 76 years of age
- •Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD
排除标准
- •History of pre-existing brain disease other than concussion or TBI
- •History of a premorbid disabling condition that interferes with outcome assessments
- •Contraindication to GH therapy
- •Type I and II Diabetes mellitus
- •Active malignant disease
- •Acute critical illness, heart failure, or acute respiratory failure
- •Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.
结局指标
主要结局
Cognitive functions- Processing Speed
时间窗: From baseline to 1-year post-treatment
To assess change in Processing Speed from baseline to 1 yr post-treatment. Processing speed will be reported as an index score based on scaled scores of digit symbol subtest and symbol search subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning. Trail Making Test A will also be used to assess processing speed. Reported as T-score. Higher scores reflect better performance.
Cognitive functions- Executive Function.
时间窗: From baseline to 1-year post-treatment
To assess change in Executive Function from baseline to 1 yr post-treatment. Trail Making Test B and verbal fluency (letter and category) will be used to assess executive function. Reported as T-score. T scores have a mean of 50 and a standard deviation of 10. Scores range from 13 to 87. Higher scores reflect better performance.
Cognitive functions- ANAM ( Automated Psychological Assessment Metrics)
时间窗: From baseline to 1-year post-treatment
To assess change in ANAM from baseline to 1 yr post-treatment. ANAM Test System- Core Battery will be used to assess this outcome measure. Reported as a standard score
Cognitive functions- Verbal learning and memory
时间窗: From baseline to 1-year post-treatment
To assess change in Verbal learning and memory from baseline to 1 yr post-treatment. California verbal learning test will be used to assess this outcome measure. Reported as a standard score with a mean of 0 and a standard deviation of 1. Scores range from -0.5 to +5.0. Higher scores reflect better performance.
Cognitive functions- Working Memory
时间窗: From baseline to 1-year post-treatment
To assess change in working memory from base line to 1 yr post-treatment. Working memory will be reported as an index score based on scaled scores for the digit span subtest and symbol span subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning.
次要结局
- MRI(One year (from baseline to 1-year post-treatment))
- Change in Physical function- Peak O2 consumption (Vo2 max)(One year (from baseline to 1-year post-treatment))
- Adverse events(One year (from baseline to 1-year post-treatment))
- Change in Physical function-DEXA measure(One year (from baseline to 1-year post-treatment))
- Change in QEEG Markers- Connectivity Measures(One year (from baseline to 1-year post-treatment))
- Quality of Life Assessment of Growth Hormone Deficiency in Adults(One year (from baseline to 1-year post-treatment))
- Change in QEEG Markers- power spectra(One year (from baseline to 1-year post-treatment))
- Change in Physical function- Maximum grip strength(One year (from baseline to 1-year post-treatment))
- Change in Physical function- Isokinetic knee extension peak torque(One year (from baseline to 1-year post-treatment))