Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.
研究概览
简要总结
Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).
详细描述
This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 21 and older.
- •Documented moderate to severe traumatic brain injury at least one year post injury.
排除标准
- •The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study.
- •Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study.
- •Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
- •Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
研究组 & 干预措施
Human Growth Hormone
recombinant human growth hormone (rhGH) self administered daily for one year
干预措施: Recombinant human growth hormone (Drug)
结局指标
主要结局
Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.
时间窗: one year
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Maximum Oxygen Uptake at Baseline.
时间窗: baseline
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Minute Ventilation at Baseline.
时间窗: baseline
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.
时间窗: one year
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Respiratory Exchange Ratio at Baseline.
时间窗: baseline
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.
时间窗: one year
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Oxygen Pulse at Baseline.
时间窗: baseline
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.
时间窗: one year
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
次要结局
- Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.(One year)
- Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.(baseline)
- Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.(baseline)
- Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.(One year)
- Neuropsychological Function as Measured by Processing Speed Index at Baseline(baseline)
- Neuropsychological Function as Measured by Digit Span Total at Baseline(baseline)
- Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Neuropsychological Function as Measured by Letter Fluency at Baseline(baseline)
- Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy(one year)
- Depression as Measured by the Beck Depression Inventory at Baseline.(baseline)
- Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline(baseline)
- Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline(baseline)
- Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy(one year)
- Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.(one year)
- Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.(baseline)
- Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.(baseline)
- Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.(baseline)
- Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.(baseline)
- Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline(baseline)
- Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.(baseline)
- Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.(baseline)
- Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.(baseline)
- Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Fatigue as Measured Using Fatigue Severity Scale at Baseline.(baseline)
- Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.(one year)
- Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy(one year)
- Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline(baseline)
- Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy(one year)
- Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.(baseline)
- Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.(one year)
- Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.(baseline)
- Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy(one year)
- Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline(baseline)
- Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.(one year)
- Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.(baseline)
- Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy(one year)
- Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.(baseline)
- Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.(one year)