Growth Hormone Replacement Therapy for Retried Professional Football Players

  • STATUS
    Recruiting
  • End date
    Sep 6, 2024
  • participants needed
    42
  • sponsor
    Center for Neurological Studies
Updated on 6 August 2021
growth hormone

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).

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.

Details
Condition Growth Hormone Deficiency, Sport Injury, Traumatic Brain Injury, Total Body Irradiation, Concussion, total-body irradiation, GH deficiency, Pituitary Disorders, Hypopituitarism, Pituitary Disease, traumatic brain injury (tbi), Brain Injury
Treatment Placebo, Growth hormone
Clinical Study IdentifierNCT04121780
SponsorCenter for Neurological Studies
Last Modified on6 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note