NCT04121780 · Center for Neurological Studies
Growth Hormone Replacement Therapy for Retried Professional Football Players
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, parallel-group trial with an where both patients and doctors know the treatment given extension to evaluate the effectiveness of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).
View original scientific description
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).
Interventions
BIOLOGICAL
Growth Hormone
Daily self-injections by subjects: 1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase
OTHER
Placebo
Daily self-injections by subjects: 1-year double-blind phase
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- The subject is willing to provide a signed and dated informed consent indicating that he understands the purpose and procedures required for the study and is willing to participate in the study.
- Former NFL player
- At least one year since retirement from football
- Less than 76 years of age
- Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD
Exclusion criteria
- History of pre-existing brain disease other than concussion or TBI
- History of a premorbid disabling condition that interferes with outcome assessments
- Contraindication to GH therapy
- Type I and II Diabetes mellitus
- Active malignant disease
- Acute critical illness, heart failure, or acute respiratory failure
- Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Where
- Dearborn, Michigan
Collaborators
Novo Nordisk A/S
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 8, 2023 · Source of record for eligibility and locations