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

UTN: U1111-1201-5972

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).

2019-10-08

2025-03-01

2026-09-01

Recruiting

Early phase I

42

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.

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2023-02-08