Growth Hormone Replacement Therapy for Retried Professional Football Players

• Register: ClinicalTrials.gov
• Last refreshed on: 20 February 2023
• Main ID: NCT04121780
• Date of registration: 25/09/2019
• Prospective Registration: Yes
• Primary sponsor: Center for Neurological Studies
• Public title: Growth Hormone Replacement Therapy for Retried Professional Football Players
• Scientific title: Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency
• Date of first enrolment: October 8, 2019
• Target sample size: 42
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT04121780
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Randall R Benson, MD
• Affiliation: Vice President and Medical Director

• Name: Vijay M Baragi, Ph.D.

• Name: Vijay Baragi, Ph.D.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 76 Years
Gender: Male

Health Condition(s) or Problem(s) studied

TBI (Traumatic Brain Injury)

Concussion, Brain

Anterior Pituitary Hyposecretion Syndrome

Hypopituitarism

Growth Hormone Deficiency

Sport Injury

Intervention(s)

Other: Placebo

Biological: Growth Hormone

Primary Outcome(s)

Cognitive functions- ANAM ( Automated Psychological Assessment Metrics) [Time Frame: From baseline to 1-year post-treatment]

Cognitive functions- Verbal learning and memory [Time Frame: From baseline to 1-year post-treatment]

Cognitive functions- Working Memory [Time Frame: From baseline to 1-year post-treatment]

Cognitive functions- Processing Speed [Time Frame: From baseline to 1-year post-treatment]

Cognitive functions- Executive Function. [Time Frame: From baseline to 1-year post-treatment]

Secondary Outcome(s)

Change in Physical function- Peak O2 consumption (Vo2 max) [Time Frame: 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)]

Change in Physical function- Isokinetic knee extension peak torque [Time Frame: One year (from baseline to 1-year post-treatment)]

Adverse events [Time Frame: One year (from baseline to 1-year post-treatment)]

MRI [Time Frame: 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)]

Quality of Life Assessment of Growth Hormone Deficiency in Adults [Time Frame: 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)]

Change in Physical function-DEXA measure [Time Frame: One year (from baseline to 1-year post-treatment)]

Secondary ID(s)

UTN: U1111-1201-5972

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Novo Nordisk A/S