NCT02988687

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Garcia, Jose M., MD, PhD · Individual
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Adult-Onset Growth Hormone Deficiency

Timeline

• Start date: 2016-11-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2016-12-09
• Last updated: 2023-03-06

Locations

1 site across 1 country: United States