Phase 4
N=15
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Growth Hormone Deficiency · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT00957671 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Maximum Oxygen Uptake at Baseline. — 29.0 mL/kg/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Recombinant human growth hormone (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Oxygen Uptake at Baseline. |
29.0 | — |
| PRIMARY Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy. |
32.1 | — |
| PRIMARY Minute Ventilation at Baseline. |
90.4 | — |
| PRIMARY Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy. |
102.4 | — |
| PRIMARY Respiratory Exchange Ratio at Baseline. |
1.27 | — |
| PRIMARY Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy. |
1.27 | — |
| PRIMARY Oxygen Pulse at Baseline. |
15.2 | — |
| PRIMARY Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy. |
16.4 | — |
| SECONDARY Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline. |
45.7 | — |
| SECONDARY Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy. |
51.0 | — |
| SECONDARY Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline. |
9.9 | — |
| SECONDARY Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy. |
11.2 | — |
| SECONDARY Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline |
18.7 | — |
| SECONDARY Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy. |
22.7 | — |
| SECONDARY Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline |
7.2 | — |
| SECONDARY Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy |
9.1 | — |
| SECONDARY Neuropsychological Function as Measured by Digit Span Total at Baseline |
16.0 | — |
| SECONDARY Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy. |
17.0 | — |
| SECONDARY Neuropsychological Function as Measured by Processing Speed Index at Baseline |
102.3 | — |
| SECONDARY Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy. |
106.6 | — |
| SECONDARY Neuropsychological Function as Measured by Letter Fluency at Baseline |
38.5 | — |
| SECONDARY Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy |
35.4 | — |
| SECONDARY Depression as Measured by the Beck Depression Inventory at Baseline. |
13.8 | — |
| SECONDARY Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy. |
6.2 | — |
| SECONDARY Fatigue as Measured Using Fatigue Severity Scale at Baseline. |
44.3 | — |
| SECONDARY Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy. |
34.0 | — |
| SECONDARY Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline. |
206.0 | — |
| SECONDARY Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. |
209.6 | — |
| SECONDARY Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline. |
175.2 | — |
| SECONDARY Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. |
182.6 | — |
| SECONDARY Muscle Fatigue as Measured by Biodex Pro 4 at Baseline. |
35.1 | — |
| SECONDARY Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy. |
36.9 | — |
| SECONDARY Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. |
96.04 | — |
| SECONDARY Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. |
96.55 | — |
| SECONDARY Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline |
61.68 | — |
| SECONDARY Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. |
63.70 | — |
| SECONDARY Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. |
31.19 | — |
| SECONDARY Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. |
29.67 | — |
| SECONDARY Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. |
32.47 | — |
| SECONDARY Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. |
30.5 | — |
| SECONDARY Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline. |
131.5 | — |
| SECONDARY Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy |
130.7 | — |
| SECONDARY Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline |
103.9 | — |
| SECONDARY Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy |
99.6 | — |
| SECONDARY Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline. |
3.78 | — |
| SECONDARY Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy. |
3.17 | — |
| SECONDARY Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. |
75.64 | — |
| SECONDARY Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy |
76.54 | — |
| SECONDARY Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline |
43.84 | — |
| SECONDARY Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. |
44.92 | — |
| SECONDARY Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. |
29.31 | — |
| SECONDARY Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy |
29.15 | — |
| SECONDARY Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline. |
38.92 | — |
| SECONDARY Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy. |
38.74 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00957671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.