Growth Hormone Replacement Therapy for Retried Professional Football Players
Interventional Study of Growth Hormone Replacement Therapy in Retired Professional Football Players With Growth Hormone Deficiency
Center for Neurological Studies
42 participants
Oct 8, 2019
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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
Daily self-injections by subjects: 1-year double-blind phase
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04121780