Growth Hormone Replacement Therapy for Retried Professional Football Players

Launched by CENTER FOR NEUROLOGICAL STUDIES · Oct 8, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating whether growth hormone (GH) therapy can help improve thinking and memory skills in retired professional football players who have a growth hormone deficiency (GHD). The study is specifically looking at men aged 65 to 75 who have played in the NFL and have been retired for at least a year. To participate, these men must have been diagnosed with GHD by both a neurologist and an endocrinologist.

Participants in the trial will be randomly assigned to receive either the growth hormone treatment or a placebo (a treatment that looks like the real thing but has no active ingredients) for a set period. Everyone involved will not know which treatment they are receiving, which helps ensure the study's fairness. After the initial phase, there will be an open-label extension, meaning that participants may receive the actual treatment after the study's main assessments. It's important for potential participants to understand that certain health issues, like diabetes or serious illnesses, may prevent them from joining the trial. If you or someone you know fits the criteria and is interested in improving cognitive health after a sports career, this study could be a valuable option to consider.

Gender

MALE

Eligibility 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.