Growth Hormone Replacement Therapy for Retried Professional Football Players

Purpose

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).

Conditions

  • TBI (Traumatic Brain Injury)
  • Concussion, Brain
  • Sport Injury
  • Anterior Pituitary Hyposecretion Syndrome
  • Hypopituitarism
  • Growth Hormone Deficiency

Eligibility

Eligible Ages
Between 18 Years and 76 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A randomized, double-blind, placebo-controlled trial with an open-label extension
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
3-D printing used to design matching cases (covers) for both the drug and placebo autoinjector pens

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Growth Hormone 		Norditropin® (somatropin [rDNA origin] injection) via FlexPro® 30 mg / 3ml strength auto-injector pens (Novo Nordisk Inc).
  • Biological: Growth Hormone
    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
    Other names:
    • Norditropin® (somatropin [rDNA origin] injection)
Placebo Comparator
Saline 		Saline-placebo via auto-injector pens (Haselmeier Inc).
  • Other: Placebo
    Daily self-injections by subjects: 1-year double-blind phase

Recruiting Locations

Center for Neurolgoical Studies (CNS)
Dearborn, Michigan 48126
Contact:
Vijay Baragi, Ph.D.
313-228-0930
vijay@neurologicstudies.com

More Details

Status
Recruiting
Sponsor
Center for Neurological Studies

Study Contact

Vijay M Baragi, Ph.D.
313-228-0930.
vijay@neurologicstudies.com

Detailed Description

GHD is the most common anterior pituitary abnormality after traumatic brain injury (TBI). It can occur as a result of either direct pituitary or indirect hypothalamic injury. Sports-related repetitive head trauma might induce pituitary dysfunction, and in particular, isolated GHD. Growth hormone replacement therapy (GHRT) has long been known to have a beneficial effect on body composition and exercise capacity. However, it has recently been shown that GHRT also benefits the brain. The primary objective of the current study is to assess the effect of GH on memory, executive function and attention domains of cognitive function in GHD- professional football players with TBI. The study will also utilize the adult growth hormone deficiency assessment (AGHDA) questionnaire, quantitative electroencephalogram (QEEG) and magnetic resonance imaging (MRI) techniques, respectively, to measure the quality of life (QoL), electrical activity and structural changes in the brain that may correspond to cognitive deficits.