RECRUITING

Growth Hormone Replacement Therapy for Retried Professional Football Players

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2019-10-08
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04121780

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 76 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Former NFL player
  3. * At least one year since retirement from football
  4. * Less than 76 years of age
  5. * Diagnosis of GHD on clinical grounds by a neurologist and an endocrinologist GHD
  1. * History of pre-existing brain disease other than concussion or TBI
  2. * History of a premorbid disabling condition that interferes with outcome assessments
  3. * Contraindication to GH therapy
  4. * Type I and II Diabetes mellitus
  5. * Active malignant disease
  6. * Acute critical illness, heart failure, or acute respiratory failure
  7. * Subjects who are deficient in cortisol, testosterone or thyroid at screening will be excluded until hormone abnormalities have been corrected.

Contacts and Locations

Study Contact

Vijay M Baragi, Ph.D.
CONTACT
313-228-0930.
vijay@neurologicstudies.com
John Russell
CONTACT
3132280930
JDR@neurologicstudies.com

Principal Investigator

Randall R Benson, MD
PRINCIPAL_INVESTIGATOR
Vice President and Medical Director

Study Locations (Sites)

Center for Neurolgoical Studies (CNS)
Dearborn, Michigan, 48126
United States

Collaborators and Investigators

Sponsor: Center for Neurological Studies

  • Randall R Benson, MD, PRINCIPAL_INVESTIGATOR, Vice President and Medical Director

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-08
Study Completion Date2026-09

Study Record Updates

Study Start Date2019-10-08
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • TBI
  • GHD
  • Growth Hormone
  • Norditropin Flexpro
  • cognition disorders

Additional Relevant MeSH Terms

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