Growth Hormone Replacement Therapy in Veterans with Gulf War Illness and GH Deficiency
Abstract
Veterans suffering from Gulf War Illness (GWI) often complain of a number of symptoms including fatigue, chronic pain, depression, anxiety, and cognitive dysfunction. The factors contributing to these symptoms are not fully understood; however, adults with adult growth hormone deficiency (AGHD) often complain of the same symptoms. Our preliminary data shows that 1 in 3 Veterans with a confirmed diagnosis of GWI tests positive for AGHD. Growth hormone replacement in civilians with AGHD due to other causes, such as brain tumors, significantly improves cognitive function, depression and fatigue, and increases their satisfaction with life. However, the effect of growth hormone replacement in Veterans with GWI has not been studied. We propose to perform a clinical trial of growth hormone replacement compared to placebo in Gulf War (GW) Veterans with GWI and AGHD. We seek to determine if growth hormone replacement can improve body composition (proportion of muscle and fat in the body); reduce depression and fatigue; improve sleep quality, cognitive functioning, and emotional problems; and increase overall quality of life in GW Veterans. This is an exploratory study that will provide important information about the possibilities of treating Veterans with GWI and growth hormone deficiency, as well as the safety of the replacement treatment. We expect that, in order to identify 36 patients with AGHD, we will need to screen 180 GW Veterans. Overall, this information will be essential to plan a larger study to unveil the efficacy of growth hormone therapy in Veterans with GWI. This study is the indispensable and economically wise first step towards deciding if a nation-wide study is worth pursuing to determine the efficacy of growth hormone replacement therapy among Veterans with GWI and the best strategy to do it. The risks of this type of therapy are minimal in this population (possible side effects include headache, muscle ache, joint discomfort, and swelling of hands/feet). Nevertheless, we will only include participants where this treatment is not expected to cause complications, and we will monitor participants carefully to keep any risk to a minimum. The benefits gained from the knowledge generated by this trial largely outweigh the risks posed to Veterans who decide to participate. This proposal may also have a direct and significant impact on the Veterans Health Administration’s current clinical practice guidelines. Growth hormone deficiency diagnosis in the setting of GWI is rarely sought at this time, even though growth hormone treatment is an approved treatment for patients with growth hormone deficiency. If growth hormone therapy is shown to be beneficial in this study, and these results are confirmed in a larger nation-wide study, this will translate into a large number of Veterans with GWI being screened and treated for growth hormone deficiency. Ultimately, this may alleviate some of the symptoms that affect our Veterans, maximizing their functional recovery and preventing health complications down the road. In summary, this study will provide Veterans with GWI and AGHD a novel therapeutic option. At the same time, it may allow us to classify GWI Veterans into those with and without concomitant AGHD, and it will determine the clinical significance of the association between GWI and AGHD detected in our preliminary studies. Lastly, this study will help Veterans, their caregivers, researchers, and healthcare providers communicate effectively about GWI, its symptoms, and potential treatments.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110450
Entities
People
- Ricardo Jorge
Organizations
- Michael E. DeBakey VA Medical Center
- United States Army