There is significant overlap between the symptoms of adult growth hormone deficiency (AGHD) and those of Gulf War Illness (GWI) such as fatigue, chronic pain, depression, anxiety, and cognitive dysfunction. AGHD is also associated with metabolic changes including increased truncal fat mass, dyslipidemia, and increased cerebrovascular risk which can lead to neuroinflammation, neurodegeneration, and functional decline.~Growth hormone replacement therapy (GHRT) reverses body composition and metabolic changes. Studies on civilians with AGHD caused by other conditions such as brain tumors suggest GHRT improves fatigue, chronic pain, mood disturbance, cognitive function, and improves quality of life (QoL).~This is a phase II, randomized, double-blind, placebo-controlled, futility trial testing the efficacy and safety of GHRT as a treatment option for patients with a history of AGHD and GWI. The primary outcome is to test the efficacy of GHRT versus placebo to change truncal fat mass percentage measured by dual energy x-ray absorptiometry (DEXA).~The secondary objective is to gather high quality data to estimate the effect size of 6-months of GHRT versus placebo on 1) cardiometabolic risk factors; 2) lean body mass; 3) quality of life; 4) severity of fatigue symptoms; 5) severity of depression, anxiety, and stress symptoms; and 6) pain severity and pain interference.
This is a placebo-controlled, double-blind, parallel, Randomized Controlled Trial of 6 months of Growth Hormone Replacement Therapy (GHRT) vs. placebo in Veterans with a history of Gulf War Illness (GWI) and Adult Growth Hormone Deficiency (AGHD). The investigators hypothesize that GHRT will reduce truncal fat mass percentage measured by DEXA (primary outcome). This could provide those veterans with GWI and AGHD a novel therapeutic option (GHRT). The study will also examine the feasibility and safety of a larger efficacy trial.