Growth Hormone Replacement Therapy for Retried Professional Football Players

February 6, 2023 updated by: Center for Neurological Studies

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Center for Neurolgoical Studies (CNS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 1-year post-treatment
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.
From baseline to 1-year post-treatment
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.
From baseline to 1-year post-treatment
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.
From baseline to 1-year post-treatment
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
From baseline to 1-year post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year (from baseline to 1-year post-treatment)
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.
One year (from baseline to 1-year post-treatment)
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.
One year (from baseline to 1-year post-treatment)
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
One year (from baseline to 1-year post-treatment)
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.
One year (from baseline to 1-year post-treatment)
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
One year (from baseline to 1-year post-treatment)
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
One year (from baseline to 1-year post-treatment)
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
One year (from baseline to 1-year post-treatment)
Adverse events
Time Frame: One year (from baseline to 1-year post-treatment)
To assess the incidence and severity of adverse events
One year (from baseline to 1-year post-treatment)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year (from baseline to 1-year post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Neurological Studies

Collaborators

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 8, 2019

Primary Completion (ANTICIPATED)

March 1, 2025

Study Completion (ANTICIPATED)

September 1, 2026

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

October 8, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTN: U1111-1201-5972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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