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

What this Trial Is About

This research aims to evaluate the effects of growth hormone (GH) replacement therapy on cognitive functions in retired professional football players diagnosed with growth hormone deficiency (GHD) following traumatic brain injury (TBI). The study focuses on memory, executive function, and attention, using tools like the adult growth hormone deficiency assessment questionnaire, quantitative electroencephalogram (QEEG), and magnetic resonance imaging (MRI) to assess brain activity, structure, and quality of life. GHD is a common issue after TBI, often linked to pituitary injury from repetitive head trauma in sports. Participants will be randomly assigned to receive either daily self-injections of Norditropin® (somatropin) via auto-injector pens or a saline placebo during a 1-year double-blind phase. After this phase, those who received placebo may enter a 6-month open-label extension to receive the active treatment. The study compares the effects of GH therapy against placebo on cognitive and physical functions over these periods. During the study, participants will undergo various assessments including cognitive testing focused on working memory, processing speed, executive function, and verbal learning. Researchers will also evaluate physical function measures like peak oxygen consumption, grip strength, and knee extension torque. Brain activity and structure will be monitored through QEEG and MRI scans. Quality of life and safety will be tracked throughout the 1-year treatment and extension periods, with close monitoring of any adverse events.

Growth Hormone Replacement Therapy for Retried Professional Football Players