Clinical trial NCT00957671: Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Official title: Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Growth Hormone Deficiency
Traumatic Brain Injury
Keywords: TBI
Traumatic Brain injury
Growth hormone deficiency
Anterior pituitary hormone
Recombinant human growth Hormone
Genotropin
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: The Moody Foundation
First posted: 2009-08-12
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Oxygen Uptake at Baseline.
timeFrame: baseline
measure: Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Minute Ventilation at Baseline.
timeFrame: baseline
measure: Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Respiratory Exchange Ratio at Baseline.
timeFrame: baseline
measure: Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Oxygen Pulse at Baseline.
timeFrame: baseline
measure: Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
Secondary outcomes:
measure: Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.
timeFrame: baseline
measure: Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
timeFrame: One year
measure: Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.
timeFrame: baseline
measure: Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.
timeFrame: One year
measure: Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline
timeFrame: baseline
measure: Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline
timeFrame: baseline
measure: Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy
timeFrame: one year
measure: Neuropsychological Function as Measured by Digit Span Total at Baseline
timeFrame: baseline
measure: Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Neuropsychological Function as Measured by Processing Speed Index at Baseline
timeFrame: baseline
measure: Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Neuropsychological Function as Measured by Letter Fluency at Baseline
timeFrame: baseline
measure: Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy
timeFrame: one year
measure: Depression as Measured by the Beck Depression Inventory at Baseline.
timeFrame: baseline
measure: Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Fatigue as Measured Using Fatigue Severity Scale at Baseline.
timeFrame: baseline
measure: Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.
timeFrame: one year
measure: Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
timeFrame: baseline
measure: Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.
timeFrame: baseline
measure: Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.
timeFrame: baseline
measure: Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
timeFrame: baseline
measure: Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
timeFrame: baseline
measure: Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
timeFrame: baseline
measure: Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
timeFrame: baseline
measure: Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
timeFrame: baseline
measure: Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
timeFrame: one year
measure: Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline
timeFrame: baseline
measure: Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
timeFrame: one year
measure: Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.
timeFrame: baseline
measure: Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.
timeFrame: one year
measure: Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
timeFrame: baseline
measure: Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
timeFrame: one year
measure: Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
timeFrame: baseline
measure: Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
measure: Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
timeFrame: baseline
measure: Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
timeFrame: one year
measure: Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
timeFrame: baseline
measure: Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
timeFrame: one year
Other outcomes:
Locations:
city: Galveston
country: United States
facility: Transitional Learning Center
state: Texas
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
Study officials:
affiliation: The University of Texas Medical Branch at Galveston
name: Randall J Urban, M.D.
role: PRINCIPAL_INVESTIGATOR
References: