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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy

Overview

Status
Completed
Phase
Phase 3
Enrollment
72 participants (actual)
Sponsor
The University of Texas Medical Branch, Galveston · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
6 Aug 2018
Primary completion
4 Oct 2023
Completion
4 Oct 2023
First posted
13 Jun 2018
Last update posted
5 Mar 2025
Conditions
Traumatic Brain Injury · Fatigue · Cognitive Impairment · COVID-19

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021202220232024
  1. Ph 3

    Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy

    NCT03554265

    6 Aug 2018 to 4 Oct 2023

Registry summary

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.

Interventions

  • SomatropinDrug

Arms3

  • 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

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline

    Time frame · baseline

    Registry description

    Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.

  2. Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months

    Time frame · 6 months

    Registry description

    Lean body mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.

  3. Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline

    Time frame · baseline

    Registry description

    Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA at baseline.

  4. Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months

    Time frame · 6 months

    Registry description

    Fat mass will be measured in mTBI and PASC subjects by GE Lunar iDEXA after 6 months of growth hormone treatment.

Secondary outcomes(2)
  1. Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline

    Time frame · baseline

    Registry description

    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.

  2. Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months

    Time frame · 6 months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline

Lean Body Mass as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline

GroupValue (kilograms)Spread
mTBI Subjects49.911.8
Community Control Subjectsnot posted–
PASC Subjects49.613.2
Primary outcomeMean· 6 months

Lean Body Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months

GroupValue (kilograms)Spread
mTBI Subjects52.311.6
Community Control Subjectsnot posted–
PASC Subjects48.213.2
Primary outcomeMean· baseline

Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at Baseline

GroupValue (kilograms)Spread
mTBI Subjects30.812.5
Community Control Subjectsnot posted–
PASC Subjects38.113.9
Primary outcomeMean· 6 months

Fat Mass as Measured by Dual Energy X-Ra Absorptiometry (DEXA) at 6 Months

GroupValue (kilograms)Spread
mTBI Subjects31.013.3
Community Control Subjectsnot posted–
PASC Subjects34.312.3
Secondary and other outcome results(4)
Secondary outcomeMean· baseline

Basal Metabolic Rate as Measured by Resting Energy Expenditure at Baseline

GroupValue (kilocalories per day)Spread
mTBI Subjects1484260
Community Control Subjectsnot posted–
PASC Subjects1512378
Secondary outcomeMean· 6 months

Basal Metabolic Rate as Measured by Resting Energy Expenditure at 6 Months

GroupValue (kilocalories per day)Spread
mTBI Subjects1656243
Community Control Subjectsnot posted–
PASC Subjects1455292
Other pre specified outcomeMean· baseline

Cognitive Function as Measured by Montreal Cognitive Assessment at Baseline

GroupValue (score on a scale)Spread
mTBI Subjects26.02.6
Community Control Subjectsnot posted–
PASC Subjects26.22.9
Other pre specified outcomeMean· 6 months

Cognitive Function as Measured by Montreal Cognitive Assessment at 6 Months

GroupValue (score on a scale)Spread
mTBI Subjects26.52.2
Community Control Subjectsnot posted–
PASC Subjects272.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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 injection0 / 280 / 2826 / 28
Community Control SubjectsCommunity control subjects will not receive any intervention.0 / 270 / 270 / 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 injection0 / 170 / 1717 / 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

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2024

Growth hormone treatment for neurologic symptoms of post-acute sequelae of COVID-19.

Wright et al. 2024Clinical and translational sciencecited by 4

PMID 38894576PMC11187940DOI 10.1111/cts.13826PUB-38894576

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
mTBI Inclusion criteria 1. Male or female with a diagnosis of mild TBI. 2. At least 6-month post-injury. 3. Ages 18 to 70 years. 4. Participant is willing and able to give informed consent for participation in the study. mTBI Exclusion criteria 1. Unable to walk unassisted. 2. Significant heart, liver, kidney, blood or respiratory disease. 3. History of chest pain or coronary heart disease. 4. Uncontrolled Diabetes mellitus. 5. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma). 6. Recent (within 6 months) treatment with anabolic steroids or corticosteroids. 7. Current alcohol or drug abuse. 8. Premorbid history of psychiatric disorder. 9. Premorbid history of head trauma. 10. Pregnancy or become pregnant during the trial. 11. Coumadin because of the risk of bleeding with daily injections of rhGH. 12. Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected. 13. 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. 14. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease. 15. Other medical condition or medication administration deemed exclusionary by the study investigators. Control Inclusion criteria 1. Ages 18 to 70 years. 2. Participant is willing and able to give informed consent for participation in the study. Control Exclusion criteria 1. Significant heart, liver, kidney, blood or respiratory disease. 2. Uncontrolled Diabetes mellitus. 3. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma). 4. Recent (within 6 months) treatment with anabolic steroids or corticosteroids. 5. Current alcohol or drug abuse. 6. Premorbid history of psychiatric disorder. 7. Premorbid history of head trauma. 8. Pregnancy or become pregnant during the trial. 9. Subjects who are deficient in thyroid at screening will be excluded until thyroid hormone is replaced. 10. Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease. 11. Other medical condition or medication administration deemed exclusionary by the study investigators. PASC Inclusion criteria 1. Male or female with a history of COVID with diagnosis confirmed by PCR test. 2. Minimum of 6 months since diagnosis of COVID by PCR test. 3. Ages 18 to 70 years. 4. Score of 3 or higher on any question 1-3 of the Brief Fatigue Inventory (BFI) questionnaire. 5. Participant is willing and able to give informed consent for participation in the study. PASC Exclusion criteria 1. Current COVID infection. 2. Unable to walk unassisted. 3. Significant heart, liver, kidney, blood or respiratory disease as determined by Principal Investigator. 4. Uncontrolled diabetes mellitus. 5. Any history of a recently (12 months) diagnosed cancer other than a skin cancer (excluding melanoma). 6. Current alcohol or drug abuse. 7. History of psychosis. 8. Pregnancy or become pregnant during the trial. 9. Subjects who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results. 10. Other medical condition or medication administration deemed exclusionary by the study investigators.

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