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

NCT02988687 | Completed

• 1 other identifier: 00930
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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 settings.

Conditions

Adult-Onset Growth Hormone Deficiency

Keywords

fatigue; quality of life; depression; cognitive function; growth hormone; traumatic brain injury

Outcome Measures

Primary Outcomes (2)

• AGHDA change

  Quality of Life Assessment for GHD in Adults questionnaire

  baseline to 3 months

• AGHDA change

  Quality of Life Assessment for GHD in Adults questionnaire

  baseline to 6 months

Secondary Outcomes (3)

• Body composition change

  baseline to 6 months

• CVLT change

  baseline to 6 months

• DASS-21 change

  baseline to 6 months

Other Outcomes (9)

• muscle strength change

  baseline to 6 months

• Aerobic capacity change

  baseline to 6 months

• Muscle function change

  baseline to 6 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans being prescribed rhGH replacement for Adult Onset Growth Hormone Deficiency due to Traumatic Brain Injury

You may qualify if:

• OEF/OIF/OND deployment confirmed by available records
• 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 (DRRI-2)
• age \>18 years
• a history of TBI defined according to the DoD/VA guidelines and characterized by the Ohio State TBI Inventory
• history of AGH deficiency diagnosed by: a) a GH stimulatory test; or b) low plasma IGF-1 level and 3 pituitary hormone deficiencies
• have been prescribed rhGH replacement by a clinical provider
• If the Veteran is receiving psychotropic medications he should be on stable doses for at least 4 weeks before their enrollment in the study.

You may not qualify if:

• Other untreated pituitary deficiencies \[patients with other hormone deficiencies will have to be on stable replacement for at least three months before including them on the study; two months of stable replacement is required for hydrocortisone therapy for adrenal insufficiency\]
• tumors, or other causes of AGHD (e.g. childhood onset GHD, pituitary surgery, tumors, radiation)
• 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
• contraindication to rhGH therapy (e.g. hypersensitivity to rhGH or any of the components of the supplied product, including metacresol, glycerin, or benzyl alcohol)
• 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
• evidence of alcohol dependence, alcohol abuse or drug use disorder during the three months previous to enrollment in the study
• 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 (TOMM)
• 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
• use of rhGH in the previous 6 months
• active or recent (6 months) history of coronary artery or cerebrovascular disease

Sponsors & Collaborators

• Garcia, Jose M., MD, PhD: lead

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Herodes M, Le N, Anderson LJ, Migula D, Miranda G, Paulsen L, Garcia JM. Metabolic and quality of life effects of growth hormone replacement in patients with TBI and AGHD: A pilot study. Growth Horm IGF Res. 2023 Aug;71:101544. doi: 10.1016/j.ghir.2023.101544. Epub 2023 Jun 1.

  PMID: 37295336 DERIVED

MeSH Terms

Conditions

Fatigue; Depression; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 6, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)