Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
| Group | Value (kilograms) | Spread |
|---|---|---|
| mTBI Subjects | 49.9 | 11.8 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 49.6 | 13.2 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy
NCT035542656 Aug 2018 to 4 Oct 2023
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
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
No intervention
Household Control Subjects
household control subjects will not receive any intervention.
Experimental
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
Outcomes the sponsor listed as primary.
Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · 6 months
Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.
Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline
Time frame · baseline
Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day.
Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months
Time frame · 6 months
Resting Energy Expenditure will be measured by capturing the expired breath of mTBI and PASC subjects while at rest with a metabolic cart over a 30 minute time period. Data will be reported as kilocalories/day. This will be measured after 6 months of growth hormone treatment in mTBI and PASC subjects only.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (kilograms) | Spread |
|---|---|---|
| mTBI Subjects | 49.9 | 11.8 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 49.6 | 13.2 |
| Group | Value (kilograms) | Spread |
|---|---|---|
| mTBI Subjects | 52.3 | 11.6 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 48.2 | 13.2 |
| Group | Value (kilograms) | Spread |
|---|---|---|
| mTBI Subjects | 30.8 | 12.5 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 38.1 | 13.9 |
| Group | Value (kilograms) | Spread |
|---|---|---|
| mTBI Subjects | 31.0 | 13.3 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 34.3 | 12.3 |
| Group | Value (kilocalories per day) | Spread |
|---|---|---|
| mTBI Subjects | 1484 | 260 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 1512 | 378 |
| Group | Value (kilocalories per day) | Spread |
|---|---|---|
| mTBI Subjects | 1656 | 243 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 1455 | 292 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| mTBI Subjects | 26.0 | 2.6 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 26.2 | 2.9 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| mTBI Subjects | 26.5 | 2.2 |
| Community Control Subjects | not posted | – |
| PASC Subjects | 27 | 2.3 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| mTBI SubjectsmTBI 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 Somatropin: Genotropin given by injection | 0 / 28 | 0 / 28 | 26 / 28 |
| Community Control SubjectsCommunity control subjects will not receive any intervention. | 0 / 27 | 0 / 27 | 0 / 27 |
| PASC SubjectsPASC 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 Somatropin: Genotropin given by injection | 0 / 17 | 0 / 17 | 17 / 17 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
PubMed tag: none · 2024
Wright et al. 2024Clinical and translational sciencecited by 4
PMID 38894576PMC11187940DOI 10.1111/cts.13826PUB-38894576
Who could join, as posted.
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