NCT00957671

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2003

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 15, 2018

Completed
Last Updated

June 29, 2018

Status Verified

May 1, 2018

Enrollment Period

11.9 years

First QC Date

August 10, 2009

Results QC Date

February 1, 2018

Last Update Submit

May 29, 2018

Conditions

Growth Hormone DeficiencyTraumatic Brain Injury

Keywords

TBITraumatic Brain injuryGrowth hormone deficiencyAnterior pituitary hormoneRecombinant human growth HormoneGenotropin

Outcome Measures

Primary Outcomes (8)

  • Maximum Oxygen Uptake at Baseline.

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

    baseline

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

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

    one year

  • Minute Ventilation at Baseline.

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

    baseline

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

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

    one year

  • Respiratory Exchange Ratio at Baseline.

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

    baseline

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

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

    one year

  • Oxygen Pulse at Baseline.

    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.

    baseline

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

    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.

    one year

Secondary Outcomes (46)

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

    baseline

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

    One year

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

    baseline

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

    One year

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

    baseline

  • +41 more secondary outcomes

Study Arms (1)

Human Growth Hormone

EXPERIMENTAL

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

Drug: Recombinant human growth hormone

Interventions

Recombinant human growth hormoneDRUG

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)

Also known as: Genotropin, Somatropin, hGH
Human Growth Hormone

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 21 and older.
  • Documented moderate to severe traumatic brain injury at least one year post injury.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Transitional Learning Center

Galveston, Texas, 77550, United States

Location

The University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Dwarfism, PituitaryBrain Injuries, Traumatic

Interventions

Growth HormoneHuman Growth Hormone

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Randall Urban, MD
Organization
University of Texas Medical Branch
rurban@utmb.edu
409-772-1176

Study Officials

  • Randall J Urban, M.D.

    The University of Texas Medical Branch at Galveston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 12, 2009

Study Start

November 1, 2003

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

June 29, 2018

Results First Posted

May 15, 2018

Record last verified: 2018-05

Locations

US(2)