Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00957671
• Date of registration: 10/08/2009
• Prospective Registration: No
• Primary sponsor: The University of Texas Medical Branch, Galveston
• Public title: Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
• Scientific title: Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
• Date of first enrolment: November 2003
• Target sample size: 15
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00957671
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Randall J Urban, M.D.
• Affiliation: The University of Texas Medical Branch at Galveston

Key inclusion & exclusion 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.



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Traumatic Brain Injury

Intervention(s)

Drug: Recombinant human growth hormone

Primary Outcome(s)

Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Minute Ventilation at Baseline. [Time Frame: baseline]

Respiratory Exchange Ratio at Baseline. [Time Frame: baseline]

Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Maximum Oxygen Uptake at Baseline. [Time Frame: baseline]

Oxygen Pulse at Baseline. [Time Frame: baseline]

Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Secondary Outcome(s)

Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy [Time Frame: one year]

Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

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]

Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy [Time Frame: one year]

Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. [Time Frame: baseline]

Neuropsychological Function as Measured by Processing Speed Index at Baseline [Time Frame: baseline]

Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline [Time Frame: baseline]

Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline. [Time Frame: baseline]

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]

Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy [Time Frame: one year]

Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy [Time Frame: one year]

Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. [Time Frame: baseline]

Fatigue as Measured Using Fatigue Severity Scale at Baseline. [Time Frame: baseline]

Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy. [Time Frame: one year]

Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. [Time Frame: baseline]

Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. [Time Frame: baseline]

Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. [Time Frame: baseline]

Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

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]

Depression as Measured by the Beck Depression Inventory at Baseline. [Time Frame: baseline]

Muscle Fatigue as Measured by Biodex Pro 4 at Baseline. [Time Frame: baseline]

Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline [Time Frame: baseline]

Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline. [Time Frame: baseline]

Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline [Time Frame: baseline]

Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline [Time Frame: baseline]

Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. [Time Frame: baseline]

Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline. [Time Frame: baseline]

Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy [Time Frame: one year]

Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline. [Time Frame: baseline]

Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

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]

Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline [Time Frame: baseline]

Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy. [Time Frame: one year]

Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline. [Time Frame: baseline]

Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. [Time Frame: one year]

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]

Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline. [Time Frame: baseline]

Neuropsychological Function as Measured by Digit Span Total at Baseline [Time Frame: baseline]

Neuropsychological Function as Measured by Letter Fluency at Baseline [Time Frame: baseline]

Secondary ID(s)

03-034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

The Moody Foundation

Results

• Results available: Yes
• Date Posted: 15/05/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00957671