Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD

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Brief Title

Metabolic and QOL Effects of GH Treatment in Patients With TBI and AGHD

Official Title

Metabolic and Quality of Life Effects of Growth Hormone Treatment in Patients With Traumatic Brain Injury and AGHD

Brief Summary

      This PILOT, NON-INTERVENTIONAL STUDY will follow patients about to start rhGH for a period of
      six months and collect valuable pilot data to evaluate feasibility of a larger study and
      treatment tolerability and compliance. The effect of rhGH on cognitive function, depression,
      fatigue, sleep quality, and QOL will also be collected. This exploratory study will also
      provide important information about recruitment and AGHD screening procedures in military

Detailed Description

      Growth hormone replacement has consistently shown improvements in body composition, exercise
      capacity, endothelial function, inflammatory biomarkers, bone mineral density, lipoprotein
      metabolism, and self-reported quality of Life (QOL) in patients suffering from adult growth
      hormone deficiency (AGHD). One of the causes for AGHD is traumatic brain injury (TBI), a
      condition that affects approximately 20% of Veterans from Operation Enduring Freedom (OEF),
      Operation Iraqi Freedom (OIF), and Operation New Dawn (OND). Because OIF/OEF/OND Veterans are
      a new population, there is a paucity of data regarding the effects of rhGH in these patients.
      The investigators propose to perform a pilot observational study of Veterans with confirmed
      adult growth hormone deficiency (AGHD) due to TBI who have been prescribed recombinant human
      growth hormone (rhGH) replacement in order to determine changes in metabolic parameters and
      QOL induced by rhGH.

      Our hypothesis is that GH replacement will improve QOL and metabolic parameters (glucose,
      insulin resistance, lipids, inflammatory markers, and body composition) in patients with
      confirmed AGHD due to TBI.The primary aim for this proposal is to determine the effects of
      rhGH treatment given daily for 6 months to Veterans with TBI and AGHD on QoL measured by the
      Quality of Life Assessment for GHD in Adults questionnaire (QoL-AGHDA, primary outcome).
      Secondary specific aims for this proposal are to gather high quality pilot data of the
      effects of 6 months of rhGH replacement in Veterans with TBI and AGHD.

Study Type


Primary Outcome

AGHDA change

Secondary Outcome

 Body composition change


Adult-Onset Growth Hormone Deficiency


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment


Start Date

November 2016

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

          1. OEF/OIF/OND deployment confirmed by available records

          2. history of combat exposure during deployment as determined by a score greater than 1
             on the Combat Experiences sub-scale of the Deployment Risk and Resilience Inventory-2

          3. age >18 years

          4. a history of TBI defined according to the DoD/VA guidelines and characterized by the
             Ohio State TBI Inventory

          5. history of AGH deficiency diagnosed by: a) a GH stimulatory test; or b) low plasma
             IGF-1 level and 3 pituitary hormone deficiencies

          6. have been prescribed rhGH replacement by a clinical provider

          7. If the Veteran is receiving psychotropic medications he should be on stable doses for
             at least 4 weeks before their enrollment in the study.

        Exclusion Criteria:

          1. Other untreated pituitary deficiencies [patients with other hormone deficiencies will
             have to be on stable replacement for at least three months before including them on
             the study; two months of stable replacement is required for hydrocortisone therapy for
             adrenal insufficiency]

          2. tumors, or other causes of AGHD (e.g. childhood onset GHD, pituitary surgery, tumors,

          3. history of neurologic or psychiatric disorder such as stroke, spinal cord injury,
             bipolar disorder, or schizophrenia that has a significant impact in the Veteran's
             functional status and QoL

          4. contraindication to rhGH therapy (e.g. hypersensitivity to rhGH or any of the
             components of the supplied product, including metacresol, glycerin, or benzyl alcohol)

          5. acute medical illness, active infection, neoplastic disease or decompensated chronic
             medical illness such as diabetes mellitus (A1c >9%), congestive heart failure or
             chronic obstructive pulmonary disease

          6. evidence of alcohol dependence, alcohol abuse or drug use disorder during the three
             months previous to enrollment in the study

          7. evidence of inadequate levels of effort in performing neuropsychological tests as
             suggested by scoring less than 41 on Trial I of the Test of Memory and Malingering

          8. due to the decreased specificity of the AGHD diagnostic tests in this setting and
             weight/size limitations of the DEXA scanner, we will exclude morbid obese subjects
             defined as having a BMI greater than 35 or body weight > 350 lbs

          9. use of rhGH in the previous 6 months

         10. active or recent (6 months) history of coronary artery or cerebrovascular disease




18 Years - 65 Years

Accepts Healthy Volunteers



, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Garcia, Jose M., MD, PhD

Study Sponsor

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Verification Date

January 2021