CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 21
- 主要终点
- QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)
研究概览
简要总结
The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OEF/OIF/OND Veteran
- •Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
- •Age 21 - 55 years old
- •One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.
- •GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), or glucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/L for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
- •Score of 11 or more on QoL-AGHDA
- •4-week stability on any psychotropic medications
- •3-month stability on all other hormone treatments
- •Able and willing to provide informed consent to participate in this study, and complete study protocol.
排除标准
- •History of moderate or severe TBI
- •History of neurologic disorder other than TBI with substantial impact on quality of life
- •History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
- •Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months.
- •Contraindication to rhGH therapy
- •Acute medical illness, active infection, cancer or decompensated chronic medical illness
- •Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.
- •Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM).
- •BMI > 40 or body weight > 350 lbs
- •Pituitary anatomy documented by an MRI using a sella protocol within the last 2 years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)
- •Women who are pregnant or of child-bearing potential not on contraception
- •Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
- •Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Other)
Growth Hormone Replacement Therapy
Recombinant Human Growth Hormone
干预措施: Somatropin (Drug)
结局指标
主要结局
QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)
时间窗: 6 months
25 question survey on quality of life; The primary objective of CSP #2018 is to determine the efficacy of rhGH, given daily for 6 months, versus placebo to improve QoL, as measured by difference in mean QoL-AGHDA score, among Veterans with a history of mTBI and AGHD (primary outcome). The primary hypothesis is that the investigators, compared to placebo, patients treated with rhGH will exhibit a 3.5-point lower mean score (higher quality of life) in QoL-AGHDA at 6 months. QoL-AGHDA: minimum score=0 (high QoL: best outcome); maximum score=25 (low QoL: worst outcome).
次要结局
- Body Composition(6 months)