Study Description:
This protocol is part of a joint collaboration with the Veterans' Administration (VA) known as (Project IN-DEPTH). The Veterans' Administration protocol will recruit and identify participants for the NIH study, and maintain a repository of data and samples through a VA protocol (VA IN-DEPTH). The NIH protocol (NIH IN-DEPTH) will conduct deep phenotyping evaluations on study participants.
Gulf War Illness (GWI) and Gulf War Chronic Multi-Symptom Illness are names that have been used to describe a disorder of fatigue, muscle and joint pain, loss of concentration, forgetfulness, headache, respiratory complaints, rashes, sleep disturbances, and/or gastrointestinal distress. The purpose of this study is to learn more about GWI from veterans deployed in Persian Gulf during the first Gulf War.
In this study, two groups of veterans who were deployed to the Persian Gulf war between August 1990 and June 1991 will be enrolled: those who are healthy veteran controls (HVC) and those with GWI. Participants will have an inpatient study visit typically lasting 14 days to explore clinical and biological phenotypes through evaluations via questionnaires, medical procedures such as exercise testing, history and physical examination, and laboratory evaluation of samples.
This protocol is a "sister study" to the NIH protocol 16-N-0058: Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS) at NIH. The symptoms of GWI and ME/CFS are very similar and much may be learned about each disorder through comparison. For this reason, the two studies will use similar methods. Participants in 16-N-0058 had previously consented to sharing of data, therefore datasets from this NIH IN-DEPTH protocol and 16-N-0058 will be shared and combined to perform several of the planned exploratory analyses.
This study will take place at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland.
Objectives: Primary Objective:
To explore and compare the clinical and biological phenotypes of veterans with GWI and healthy veteran controls (HVC) at baseline.
Exploratory Objectives:
To explore the pathophysiology of fatigue and GWI symptom flares. Fatigue will be explored using tasks designed to create muscular and cognitive fatigue. GWI symptom flares will be explored using an exercise stress test and measuring the symptomatic and biological changes.
To compare the clinical and biological phenotypes between GWI, HVC, ME/CFS, and healthy volunteers.
Endpoints: Outcome measures
The primary purpose of this protocol is to perform exploratory analysis of collected data and samples for the generation of new hypotheses regarding GWI. The types of analyses to be performed will be wide ranging. Planned areas of focus may include:
* Characterization of the immune system and inflammatory signaling.
* Characterization of the pattern of microbiome.
* Characterization of bioenergetics, autonomic, and metabolic function.
* Characterization of neurocognition.