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Growth Hormone Replacement for Retired Football Players with Growth Hormone Deficiency

This study is looking at whether Growth Hormone (BIOLOGICAL) can improve thinking skills in retired professional football players. You might be able to join if you are a former NFL player, at least one year retired, under 76 years old, and have been diagnosed with growth hormone deficiency (GHD) by a neurologist and an endocrinologist. The study aims to see if Growth Hormone improves memory, executive function (planning and decision-making), and attention. Researchers will measure these cognitive functions over one year to see if the treatment is successful. The current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with 42 participants. This means some participants will receive Growth Hormone and others a placebo (inactive substance) without knowing which they are getting.
What's involved
You would give yourself daily injections for one year. If you received the placebo during the first year, you might have the option to receive Growth Hormone for an additional six months.
Compensation
Not stated in the trial record.
Follow-up
Your cognitive functions will be measured from the start of the study up to one year after treatment begins.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04121780

Growth Hormone Replacement Therapy for Retried Professional Football Players

Recruiting
PHASE2Ages 18–76InterventionalTreatment
Center for Neurological Studies
~42 participants
Updated 2023-02-08 on ClinicalTrials.gov
What's tested:Growth HormonePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cognitive functions- Working Memory
Measured over From baseline to 1-year post-treatment
+4 more outcomes measured

Conditions

TBI (Traumatic Brain Injury)
Concussion, Brain
Sport Injury
Anterior Pituitary Hyposecretion Syndrome
Hypopituitarism
Growth Hormone Deficiency

Explore related trials

Cognitive DisorderGrowth Hormone DeficiencyTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Randall R Benson, MD · PRINCIPAL_INVESTIGATOR · Vice President and Medical Director

Who to contact

Vijay M Baragi, Ph.D.
[email protected]
313-228-0930. · ext. 103
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Cognitive functions- Working MemoryFrom 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 SpeedFrom 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.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 memoryFrom 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)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