Characterizing Growth Hormone Deficiency in Traumatic Brain Injury: Evaluation of the Growth Hormone in Adult Quality of Life Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Quality of Life in Adult Growth Hormone Deficiency Assessment (Qol-AGHDA)
研究概览
简要总结
The goal of this observational study is to characterize the impact of growth hormone deficiency (GHD) on quality of life, symptom burden, and sleep in adults with traumatic brain injury (TBI), and to evaluate whether these outcomes improve with growth hormone replacement therapy.
The main questions it aims to answer are:
- Does quality of life, as measured by the Quality of Life Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), differ between adults with TBI and GHD compared to those with TBI and no GHD?
- Do fatigue, cognition, mood, post-concussion symptoms, body image, libido, perceived stress, and sleep architecture differ between these two groups?
- Among participants with GHD who begin growth hormone replacement therapy, do symptom burden and quality of life improve over a 12-week treatment period?
Eligible participants will be asked to complete baseline questionnaires and undergo testing for growth hormone deficiency (glucagon stimulation testing). A subset of participants will also complete objective sleep assessments using actigraphy and at-home polysomnography. For those who are diagnosed with growth hormone deficiency and choose to pursue treatment, questionnaires will be repeated bi-weekly while receiving growth hormone replacement therap
详细描述
Growth hormone deficiency (GHD) is the most common chronic hormone deficit following traumatic brain injury (TBI) with variable prevalence (average of 10-15%), likely a reflection of the timing and methods of testing, age, and injury severity. Previous guidelines recommend assessment of GHD with serum IGF-1. However, studies have found IGF-1 lacks specificity and sensitivity and does not correlate with dynamic testing in patients with mild TBI and GHD.
The primary objective of this observational study is to determine whether the Quality of Life in Adult Growth Hormone Deficiency Assessment (QoL-AGHDA) can aid in predicting GHD in patients with mild TBI.
Patients aged 18-75 years with a diagnosis of mild TBI (American congress of rehabilitation 2023 guidelines and Centre for disease control and prevention definition of traumatic brain injury) with persistent symptoms at 1-year post-injury attending the Calgary Brain Injury program and the chronic pain centre will be screened for suspected GHD by physicians.
Eligible participants will complete the QoL-AGHDA along with other symptom based measures and will be referred to endocrinology for provocative testing for GHD (glucagon stimulation testing).
The secondary objective is to determine if the QoL-AGHDA can provide an objective measure of growth hormone treatment efficacy in patients with TBI and GHD. To address this, participants found to have GHD (peak GH of <3mcg/L following glucagon stimulation test) will be provided with growth hormone replacement (Genotropin, Pfizer) for 3 months. Participants will be asked to repeat questionnaires (QoL-AGHDA and additional symptom measures) bi-weekly throughout the 3-months of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-70 years must be referred and have a diagnosis of mTBI made by a brain injury specialist physician and meet the 2023 ACRM diagnostic criteria (Appendix A, Panel A) or the NIH diagnostic criteria for moderate/severe TBI (Appendix A, Panel B). All participants must be symptomatic for at least one-year post-injury (determined by the Glasgow Extended Scale score of less than 8 for moderate/severe TBI and a Rivermead Post-Concussion Questionnaire score of > 13 with 3 or more symptoms scored > 3 for mTBI), at the time of screening. All participants must also be fluent in English and be able to either complete questionnaires online or over the phone.
- •In terms of concomitant therapies and medication, all prescription and non-prescription medications (e.g., over-the-counter drugs and herbal supplements) and therapies will be recorded by participants during baseline assessments. Participants with GHD on treatment will be asked to disclose any changes in medications/and or therapies at each bi-weekly follow up questionnaires.
排除标准
- •include untreated pituitary deficits to minimize confounding factors (unless treated/consulted with Dr. Debert and/or Dr. Lithgow), other intracranial abnormalities, chronic neurological conditions, untreated medical conditions, major medical conditions in the past 6 months such as stroke, and current or planned pregnancy.
研究组 & 干预措施
Suspected Growth Hormone Deficiency
Participants attending the Calgary Brain Injury Program or Chronic Pain Centre with persistent post-concussion symptoms for over 1 year suspected of having GHD.
Participants will be asked to complete the QoL-AGHDA and additional post-concussion symptom questionnaires and referred to endocrinology for provocative testing (glucagon stimulation testing)
干预措施: Not applicable (observational study) (Other)
Growth Hormone Deficiency Treatment
Participants with GHD (peak GH of < 5 mcg/L following glucagon stimulation test (GST) will be provided with growth hormone replacement (Genotropin, starting dose 0.2 ug/L and 0.3ug/L for women taking exogenous oral estrogen, Pfizer) for 3 months.
Participants will repeat the QoL-AGHDA and exploratory outcome questionnaires bi-weekly throughout treatment (3-months).
干预措施: Not applicable (observational study) (Other)
结局指标
主要结局
Quality of Life in Adult Growth Hormone Deficiency Assessment (Qol-AGHDA)
时间窗: To be completed at baseline and repeated bi-weekly during Genotropin treatment and treatment completion (3 months)
A 25-question, self-administered, condition specific quality of life measure used to determine the extent to which growth hormone deficiency has affected the patient's quality of life. Participants are instructed to answer "yes" or "no" to statements relating to problems with memory and concentration, tiredness, tenseness, social isolation and self-confidence. Higher scores indicate greater symptom burden and lower quality of life.
Glucagon Stimulation Testing
时间窗: Baseline
Provocative glucagon stimulation testing completed by endocrinology. Peak growth hormone of less than 3mcg/L indicative of growth hormone deficiency
次要结局
- Saint Louis University Mental Status Examination (SLUMS)(To be assessed at baseline and at completion of treatment (3 months))
- Fatigue and Altered Cognition Scale (FACS)(To be repeated bi-weekly during Genotropin treatment and treatment completion (3 months))
- Patient Health Questionnaire - 9 (PHQ-9)(To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months))
- Generalized Anxiety Disorder -7 (GAD-7)(To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months))
- Rivermead Post-Concussion Symptom Questionnaire (RPQ)(To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months))
- Glasgow outcome scale extended (GOSE)(To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months))
- Sleep and Concussion Questionnaire(To be assessed at baseline, bi-weekly during Genotropin treatment and at completion of treatment (3 months))
- Sexual Desire Inventory (SDI(To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months))
- Godin Leisure-Time Questionnaire:(To be assessed at baseline and at completion of treatment (3 months))
- Body Image Scale (BIS):(To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months))
- Epworth Sleepiness Scale (ESS)(To be assessed at baseline, 4-weeks post-treatment starts and at completion of treatment (3 months))
- Perceived Stress Scale (PSS)(To be assessed at baseline, treatment start, 4-weeks post-treatment start and at completion of treatment (3 months))
- Waist Circumference:(To be assessed at baseline and at completion of treatment (3 months))
- Hand Grip Strength(To be assessed at baseline and at completion of treatment (3 months))
- Wrist Based Actigraphy(If participants have GHD, they will be asked to repeat the same actigraphy protocol for 6 nights/days with daily sleep diary completion at the 3-month post treatment mark.)
- At-home polysomnography (PSG)(Baseline)