NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)

Gulf War Illness Clinical Trial

Official title: NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)

Status Recruiting

Clinical Trial Summary

Background:

Gulf War illness (GWI) affects up to 210,000 U.S. veterans who served in the Middle East during the Gulf War in 1990-1991. Symptoms include fatigue, muscle and joint pain, forgetfulness, headaches, rashes, and sleep disturbances. Routine exams cannot determine the cause of GWI. Researchers need more information to understand this disease.

Objective:

This natural history study will look for differences in Gulf War veterans who experienced GWI and those who did not.

Eligibility:

Gulf War veterans with GWI. Healthy Gulf War veterans who do not have GWI are also needed.

Design:

Participants will stay in the NIH Clinical Center as an inpatient for 2 weeks. They will undergo many tests.

Blood will be drawn many times throughout the study. Participants will also give urine, saliva, and stool samples.

Scans to measure the brain, leg muscles, bone density and body mass will be done.

They will have an exercise stress test and muscle strength tests.

They will have a sleep study. They will have tests to look at how well the brain, heart and lungs are working.

Participants will sleep in a specialized room that measures the amount of oxygen they use and the carbon dioxide they produce on four consecutive nights.

A sample of fluid will be collected from inside the spine.

Participants will take many surveys. Some will ask about their activities. Some will be about emotional and mental health. Some will be about thinking, memory, and behavior.

Optional tests include other imaging scans and testing the autonomic nervous system. Samples of skin and muscle may be taken.

After discharge, participants will wear activity monitors for 14 days. They will keep a diary of their symptoms, including fatigue, pain, and sleep, while wearing the monitors.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Gulf War Illness

• NCT number: NCT05375812
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Angelique Gavin
• Phone: (301) 402-0880
• Email: angelique.gavin@nih.gov
• Status: Recruiting
• Start date: April 16, 2023
• Completion date: December 31, 2030