Trial · Interventional
Status unknownPhase 2Registry dataUnited States
1 trial
Growth Hormone Replacement Therapy for Retried Professional Football Players
NCT041217808 Oct 2019 to est. Sept 2026
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).
Experimental
Growth Hormone
Norditropin® (somatropin \[rDNA origin\] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
Placebo comparator
Saline
Saline-placebo via auto-injector pens (Haselmeier Inc).
Outcomes the sponsor listed as primary.
Cognitive functions- Working Memory
Time frame · From baseline to 1-year post-treatment
To assess change in working memory from base line to 1 yr post-treatment. Working memory will be reported as an index score based on scaled scores for the digit span subtest and symbol span subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning.
Cognitive functions- Processing Speed
Time frame · From baseline to 1-year post-treatment
To assess change in Processing Speed from baseline to 1 yr post-treatment. Processing speed will be reported as an index score based on scaled scores of digit symbol subtest and symbol search subtest. Index scores have a mean of 100 and a standard deviation of 15. The typical range of index score is 45 to 155. Higher scores reflect better functioning. The scaled scores have a mean of 10 and a standard deviation of 3. Scores range from 1 to 19. Higher scores reflect better functioning. Trail Making Test A will also be used to assess processing speed. Reported as T-score. Higher scores reflect better performance.
Cognitive functions- Executive Function.
Time frame · From baseline to 1-year post-treatment
To assess change in Executive Function from baseline to 1 yr post-treatment. Trail Making Test B and verbal fluency (letter and category) will be used to assess executive function. Reported as T-score. T scores have a mean of 50 and a standard deviation of 10. Scores range from 13 to 87. Higher scores reflect better performance.
Cognitive functions- Verbal learning and memory
Time frame · From baseline to 1-year post-treatment
To assess change in Verbal learning and memory from baseline to 1 yr post-treatment. California verbal learning test will be used to assess this outcome measure. Reported as a standard score with a mean of 0 and a standard deviation of 1. Scores range from -0.5 to +5.0. Higher scores reflect better performance.
Cognitive functions- ANAM ( Automated Psychological Assessment Metrics)
Time frame · From baseline to 1-year post-treatment
To assess change in ANAM from baseline to 1 yr post-treatment. ANAM Test System- Core Battery will be used to assess this outcome measure. Reported as a standard score
Quality of Life Assessment of Growth Hormone Deficiency in Adults
Time frame · One year (from baseline to 1-year post-treatment)
This measure includes a scale: It is based on the Adult Growth Hormone Deficiency Assessment (AGHDA) QoL questionnaire. It consists of 25 yes/no questions. Score ranges from 0-25 with number of "yes" responses indicating score. A score of 8 or higher is typical of untreated adult GH deficiency. Treatment, on an average, results in a decrease of 2.5 to 3 points on the scale at one year
Change in QEEG Markers- power spectra
Time frame · One year (from baseline to 1-year post-treatment)
Spectral markers include delta (1-5-2.5 Hz), theta (3.5-7.5 Hz), alpha (7.5-12.5 Hz), alpha 1 (7.5-10.0 Hz), alpha 2 (10.0-12.5 Hz), beta 1 (12.5- 25.0 Hz) , beta 2 (25.0-35.0 Hz), gamma (35.0- 50.0 Hz). The power will be averaged over all electrode sites as absolute and relative power.
Change in QEEG Markers- Connectivity Measures
Time frame · One year (from baseline to 1-year post-treatment)
Connectivity measures will include Pearson product moment correlation for the time series and coherence, phase synchronization and phase lag.
MRI
Time frame · One year (from baseline to 1-year post-treatment)
To assess changes in volumetric MRI measurements and diffusion tensor imaging (DTI) measurements
Change in Physical function- Peak O2 consumption (Vo2 max)
Time frame · One year (from baseline to 1-year post-treatment)
Measured in units of liters per minute.
Change in Physical function- Maximum grip strength
Time frame · One year (from baseline to 1-year post-treatment)
Measured in pounds using the CAMRY Digital Hand Dynamometer
Change in Physical function- Isokinetic knee extension peak torque
Time frame · One year (from baseline to 1-year post-treatment)
Measured using the Cybex II isokinetic dynamometer. The maximum torque is recorded in ft-lbs of force
Change in Physical function-DEXA measure
Time frame · One year (from baseline to 1-year post-treatment)
Percent body fat and lean mass by limb and trunk
Adverse events
Time frame · One year (from baseline to 1-year post-treatment)
To assess the incidence and severity of adverse events
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
4 studies on this page
PubMed tag: none · 2011
Reimunde et al. 2011Brain injurycited by 77
PMID 21117918DOI 10.3109/02699052.2010.536196PUB-21117918
Indexing hint: Randomized controlled trial · 2010
Jr et al. 2010Journal of neurotraumacited by 117
PMID 20578825PMC2966848DOI 10.1089/neu.2009.1253PUB-20578825
PubMed tag: none · 2004
Kelestimur et al. 2004Journal of endocrinological investigationcited by 85
PMID 15754728DOI 10.1007/bf03345299PUB-15754728
Indexing hint: Randomized controlled trial · 1998
Deijen et al. 1998Psychoneuroendocrinologycited by 132
PMID 9618751DOI 10.1016/s0306-4530(97)00092-9PUB-09618751
1 study on this page
Indexing hint: Clinical trial · 2013
Moreau et al. 2013Journal of neurotraumacited by 66
PMID 23323993DOI 10.1089/neu.2012.2705PUB-23323993
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