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NCT Number: NCT04121780

Growth Hormone Replacement Therapy for Retried Professional Football Players

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).

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Key information

Conditions

TBI (Traumatic Brain Injury) Anterior Pituitary Hyposecretion Syndrome Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Concussion, Brain Craniocerebral Trauma Dwarfism Dwarfism, Pituitary Endocrine System Diseases Growth Hormone Deficiency Head Injuries, Closed Hypopituitarism Hypothalamic Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Pituitary Diseases Sport Injury Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–76 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

About this study

GHD is the most common anterior pituitary abnormality after traumatic brain injury (TBI). It can occur as a result of either direct pituitary or indirect hypothalamic injury. Sports-related repetitive head trauma might induce pituitary dysfunction, and in particular, isolated GHD. Growth hormone replacement therapy (GHRT) has long been known to have a beneficial effect on body composition and exercise capacity. However, it has recently been shown that GHRT also benefits the brain. The primary objective of the current study is to assess the effect of GH on memory, executive function and attention domains of cognitive function in GHD- professional football players with TBI. The study will also utilize the adult growth hormone deficiency assessment (AGHDA) questionnaire, quantitative electroencephalogram (QEEG) and magnetic resonance imaging (MRI) techniques, respectively, to measure the quality of life (QoL), electrical activity and structural changes in the brain that may correspond to cognitive deficits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Growth Hormone

Biological

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 names: Norditropin® (somatropin [rDNA origin] injection)

Placebo

Other

Daily self-injections by subjects:

1-year double-blind phase

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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

  9. Adverse events

    Time frame: One year (from baseline to 1-year post-treatment)

    To assess the incidence and severity of adverse events

Other outcomes

  1. MR imaging analysis of hypothalamus and pituitary

    Time frame: One year (from baseline to 1-year post-treatment)

    for diagnosis of GHD or multiple anterior pituitary hormone deficiencies in GHD - professional football players with TBI

Study contacts

Contact information is provided by the study sponsor or research team.

John Russell

CONTACT

[email protected]

3132280930

Vijay M Baragi, Ph.D.

CONTACT

[email protected]

313-228-0930. ext. 103

Sponsors and collaborators

Lead sponsor

Center for Neurological Studies

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Oct 10, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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