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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

NCTNCT00957671 (opens ClinicalTrials.gov in a new tab)Other id03-034
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Overview

Status
Completed
Phase
Phase 4
Enrollment
15 participants (actual)
Sponsor
The University of Texas Medical Branch, Galveston · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Nov 2003
Primary completion
Oct 2015
Completion
Oct 2015
First posted
12 Aug 2009 (estimated)
Last update posted
29 Jun 2018
Conditions
Growth Hormone Deficiency · Traumatic Brain Injury

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520102015
  1. Ph 4

    Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

    NCT00957671

    Nov 2003 to Oct 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

Interventions

  • Recombinant human growth hormoneDrug

Arms1

  • Experimental

    Human Growth Hormone

    recombinant human growth hormone (rhGH) self administered daily for one year

Primary outcomes8

Outcomes the sponsor listed as primary.

  1. Maximum Oxygen Uptake at Baseline.

    Time frame · baseline

    Registry description

    Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.

  2. Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.

  3. Minute Ventilation at Baseline.

    Time frame · baseline

    Registry description

    Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.

  4. Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.

  5. Respiratory Exchange Ratio at Baseline.

    Time frame · baseline

    Registry description

    Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.

  6. Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.

  7. Oxygen Pulse at Baseline.

    Time frame · baseline

    Registry description

    Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.

  8. Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.

Secondary outcomes(20)

  1. Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.

    Time frame · baseline

    Registry description

    The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.

  2. Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.

    Time frame · One year

    Registry description

    The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.

  3. Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.

    Time frame · baseline

    Registry description

    The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.

  4. Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.

    Time frame · One year

    Registry description

    The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.

  5. Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline

    Time frame · baseline

    Registry description

    The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.

  6. Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.

  7. Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline

    Time frame · baseline

    Registry description

    The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.

  8. Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy

    Time frame · one year

    Registry description

    The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.

  9. Neuropsychological Function as Measured by Digit Span Total at Baseline

    Time frame · baseline

    Registry description

    Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.

  10. Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.

  11. Neuropsychological Function as Measured by Processing Speed Index at Baseline

    Time frame · baseline

    Registry description

    Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output. This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded. Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.

  12. Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output. This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded. Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.

  13. Neuropsychological Function as Measured by Letter Fluency at Baseline

    Time frame · baseline

    Registry description

    Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.

  14. Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy

    Time frame · one year

    Registry description

    Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.

  15. Depression as Measured by the Beck Depression Inventory at Baseline.

    Time frame · baseline

    Registry description

    Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.

  16. Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.

  17. Fatigue as Measured Using Fatigue Severity Scale at Baseline.

    Time frame · baseline

    Registry description

    Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.

  18. Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.

    Time frame · one year

    Registry description

    Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.

  19. Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.

    Time frame · baseline

    Registry description

    Maximum torque production during isometric contraction of the knee extensor muscles.

  20. Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.

    Time frame · one year

    Registry description

    Maximum torque production during isometric contraction of the knee extensor muscles.

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

Maximum Oxygen Uptake at Baseline.

GroupValue (mL/kg/min)Spread
Human Growth Hormone29.07.2
Primary outcomeMean· one year

Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.

GroupValue (mL/kg/min)Spread
Human Growth Hormone32.17.4
Primary outcomeMean· baseline

Minute Ventilation at Baseline.

GroupValue (L/minute)Spread
Human Growth Hormone90.424.2
Primary outcomeMean· one year

Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.

GroupValue (L/minute)Spread
Human Growth Hormone102.423.1
Primary outcomeMean· baseline

Respiratory Exchange Ratio at Baseline.

GroupValue (ratio of CO2/O2)Spread
Human Growth Hormone1.270.12
Primary outcomeMean· one year

Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.

GroupValue (ratio of CO2/O2)Spread
Human Growth Hormone1.270.10
Primary outcomeMean· baseline

Oxygen Pulse at Baseline.

GroupValue (mL/beat)Spread
Human Growth Hormone15.24.1
Primary outcomeMean· one year

Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.

GroupValue (mL/beat)Spread
Human Growth Hormone16.44.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Human Growth Hormonerecombinant human growth hormone (rhGH) self administered daily for one year. Human Growth Hormone: 200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total).0 / 150 / 150 / 15

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 21 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patients aged 21 and older. * Documented moderate to severe traumatic brain injury at least one year post injury. Exclusion Criteria: * The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study. * Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study. * Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected. * 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.

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