Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
研究概览
简要总结
Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period.
详细描述
The investigators will study subjects (aged 18-70 years) with a history of mild TBI (n=25), post-acute sequelae of SARS-CoV-2 (PASC) (n=25)and healthy controls (n=25). mTBI subjects will undergo a 6-month intervention of rhGH therapy. PASC subjects will undergo a 9-month intervention of rhGH therapy. Controls will be asked to participate in questionnaires, blood draws (amino acid analysis), and fecal sampling (GI microbiome analysis). Controls will not receive any growth hormone treatment.
mTBI group
All patients presenting with a prior mTBI will undergo a phone pre-screen including the Brief Fatigue Inventory (BFI) questions 1-3. If they score ≥ 3 on any BFI questions 1-3, and are interested in participating in the study, they will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC). During the medical screening, eligibility will be confirmed and a glucagon stimulation test (GST) will be performed. A glucagon stimulation with a growth hormone peak of <10 ng/mL is required to qualify for enrollment.
PASC group
All patients presenting with PASC will undergo a phone pre-screen including the Brief Fatigue Inventory (BFI) questions 1-3. If they score ≥ 3 on any BFI questions 1-3, and are interested in participating in the study, they will be scheduled for a formal consenting and medical screening at the UTMB Clinical Research Center (CRC). During the medical screening, eligibility will be confirmed and a glucagon stimulation test (GST) will be performed. A glucagon stimulation with a growth hormone peak of <10 ng/mL is required to qualify for enrollment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
mTBI subjects
mTBI subjects will receive recombinant human growth hormone replacement therapy daily for 6 months.
Drug: recombinant human growth hormone (rhgH); somatropin, Genotropin
Dose: month 0 - month 1 will be dosed at 0.4 mg / day month 1 - month 6 will be dosed at 0.6 mg / day
干预措施: Somatropin (Drug)
PASC subjects
PASC subjects will receive recombinant human growth hormone replacement therapy daily for 9 months.
Drug: recombinant human growth hormone (rhgH); somatropin, Genotropin
Dose: month 0 - month 1 will be dosed at 0.4 mg / day month 1 - month 9 will be dosed at 0.6 mg / day
干预措施: Somatropin (Drug)
结局指标
主要结局
Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
时间窗: baseline
Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.
Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months
时间窗: 6 months
Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline
时间窗: baseline
Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.
Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months
时间窗: 6 months
Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.
次要结局
- Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline(baseline)
- Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months(6 months)