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Growth Hormone Replacement Therapy for Retried Professional Football Players

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ClinicalTrials.gov Identifier: NCT04121780
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Center for Neurological Studies

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Concussion, Brain Sport Injury Anterior Pituitary Hyposecretion Syndrome Hypopituitarism Growth Hormone Deficiency Biological: Growth Hormone Other: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, double-blind, placebo-controlled trial with an open-label extension
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: 3-D printing used to design matching cases (covers) for both the drug and placebo autoinjector pens
Primary Purpose: Treatment
Official Title: Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : September 2023


Arm Intervention/treatment
Experimental: Growth Hormone
Norditropin® (somatropin [rDNA origin] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
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 Name: Norditropin® (somatropin [rDNA origin] injection)

Placebo Comparator: Saline
Saline-placebo via auto-injector pens (Haselmeier Inc).
Other: Placebo

Daily self-injections by subjects:

1-year double-blind phase





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121780


Contacts
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Contact: Vijay M Baragi, Ph.D. 313-228-0930. ext 103 vijay@neurologicstudies.com
Contact: John Russell 3132280930 JDR@neurologicstudies.com

Locations
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United States, Michigan
Center for Neurolgoical Studies (CNS) Recruiting
Dearborn, Michigan, United States, 48126
Contact: Vijay Baragi, Ph.D.    313-228-0930    vijay@neurologicstudies.com   
Contact: John Russell    3132280930    JDR@neurologicstudies.com   
Sponsors and Collaborators
Center for Neurological Studies
Novo Nordisk A/S
Investigators
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Principal Investigator: Randall R Benson, MD Vice President and Medical Director

Additional Information:
Publications:

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Responsible Party: Center for Neurological Studies
ClinicalTrials.gov Identifier: NCT04121780     History of Changes
Other Study ID Numbers: UTN: U1111-1201-5972
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Center for Neurological Studies:
TBI
GHD
Growth Hormone
Norditropin Flexpro
cognition disorders
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Brain Injuries
Brain Injuries, Traumatic
Hypopituitarism
Brain Concussion
Athletic Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Pituitary Diseases
Hypothalamic Diseases
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Head Injuries, Closed
Wounds, Nonpenetrating
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs