- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03082638
Identification of Gulf War Illness (GWI) Biomarkers
Identification of Lipid Biomarkers of Inflammation and Metabolic Disturbances in Gulf War Illness (GWI)
The scientists working on this study want to use blood samples to identify components in blood, such as protein, lipids and their breakdown products to determine if they can be used for diagnosing Gulf War Illness (GWI). An additional goal is to examine the relationship of changes in these markers with the exposures and symptoms associated with GWI.
The Scientists will also prepare RNA and DNA from the blood samples for genetic analyses of certain proteins known to increase the risk for GWI. This information will be one of the factors included in the analysis of results from the protein studies.
Study Overview
Status
Conditions
Detailed Description
Research studies conducted over the last decade provide compelling evidence that Gulf War Illness (GWI) may have been caused by exposure to chemicals, such as an anti-nerve agent pyridostigmine bromide (PB) and different types of pesticides (GW agents). These studies also show that brain structures that are involved in processing and storing memory, as well as brain pathways involved in controlling pain and fatigue, are altered in GW veterans with this condition. Even now, nearly 25 years later, veterans with GWI continue to experience these complex symptoms and this illness remains difficult to diagnose since the current GWI diagnostic process are limited by having to use information on self-reporting of symptoms. As such, there remains a need for developing minimally invasive blood based disease markers (biomarker) of GWI. The goal of this current study is to identify novel biomarkers of GWI which can assist physicians in providing an objective diagnosis of GWI so that appropriate clinical evaluations and treatments can be provided to GW veterans with this condition. Another key goal of this project is to identify biomarkers of GW chemical exposure and symptom profiles so that care and treatment can be tailored individually for each veteran with GWI. Scientists working in the field of GWI research continue to provide strong evidence that this condition is connected with irregular responses by blood cells which generally combat irritations or other injuries to the body (inflammation). Scientists have also found that GWI could also be due to damage to mitochondria, known as the powerhouses responsible for generating energy through the breakdown of sugars and fats (lipids).
Scientists at the Roskamp Institute have developed mouse models of GWI in order to identify biomarkers of brain damage and neurobehavioral problems that are a direct consequence of chemicals to which GW veterans were exposed during the 1991 GW. They have identified that there might be problems with breaking down fats in the brains of exposed mice even long after subacute exposure to GW agents. In particular, they show changes in lipids which belong to cellular compartments (peroxisomes) that perform tasks similar to those of the mitochondria with respect to the breakdown of fats. The inflammatory processes, mitochondria and peroxisomes display unique lipid classes that can be measured in blood using mass spectrometry technologies. These technologies allow us to detect and measure elemental composition of each lipid. We plan to use this technology to study lipids that are specific to inflammation and metabolic disturbances associated with GWI in order to determine if they can be used as biomarkers of GWI. In collaboration with the Boston GWI consortium, we are testing this hypothesis and our early pilot work in control and GWI veterans support potential use of these lipids as biomarkers of GWI. The proposal will expand these pilot studies and determine if lipids associated with these key disturbances in GWI can be useful tools for diagnosing GWI. The proposal will also try to use these lipids in order to identify subgroups of GW veterans with similar chemical exposures and symptom patterns. This work will also be facilitated by the use of blood samples from GWI animal models that will help with translational studies linking animal model work and human studies. This will help fill the gaps between the two so that future studies can be conducted that can use these biomarkers to determine if treatments and care designed for GWI are succeeding.
Furthermore, identifying biomarkers of exposures and symptom profiles which will help with delivering personalized care and treatment to each veteran appropriately. The existing expertise and collaborations between the Roskamp Institute and the Boston GWI consortium will expedite successful translation of this endeavor so that appropriate biomarker tools are made available to the clinicians in order to assist them with diagnosing GWI and ensuring that appropriate medical plans are developed for the care and treatment of veterans with GWI.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Sarasota, Florida, United States, 34243
- The Roskamp Institute, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
1. Age 35 years or older 2. Served in the 1990-1991 Gulf War 3. Ability to understand written and spoken English or availability of a legal representative who can understand written or spoken English. Participants and caregiver/informants must be able to read, write and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate testing.
-
Exclusion Criteria:
- Diagnosed or being treated by a physician for any of the following (Steele et al, 2000) and deemed clinically significant per the discretion of the PI:
- Cancer (except for non-melanoma skin cancers)
- Chronic infectious disease
- Problems resulting from postwar injuries.
- Liver disease
- Lupus
- Multiple sclerosis
- Stroke
- Serious psychiatric condition (those associated with psychosis and/or for which the respondent had been hospitalized since 1991).
- Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).
Diagnosis of Dementia of any type or Parkinson's disease
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Control
served in Gulf War during 1990 - 1991 and have no symptoms of Gulf War Illness based on criteria
|
Case
Served in Gulf War during 1990 -1991 and have Gulf War Illness
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid bio markers
Time Frame: 2017 to 2019
|
Determine if lipids specific to inflammation, mitochondria and peroxisome function can be objective biomarkers of the CNS pathology of GWI.
|
2017 to 2019
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of Subgroups
Time Frame: 2017 to 2019
|
determine if lipid biomarkers can identify subgroups of ill GW veterans based on symptom patterns and GW chemical exposures.
|
2017 to 2019
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laila Abdullah, PhD, The Roskamp Institute, Inc
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RI-GWI-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gulf War Illness
-
National Institute of Neurological Disorders and...RecruitingGulf War IllnessUnited States
-
East Carolina UniversityCompletedGulf War IllnessUnited States
-
K-PAX Pharmaceuticals, Inc.VA Palo Alto Health Care SystemUnknownGulf War IllnessUnited States
-
Nova Southeastern UniversityBoston University; RTI InternationalRecruiting
-
VA Office of Research and DevelopmentTexas A&M UniversityTerminatedGulf War IllnessUnited States
-
Icahn School of Medicine at Mount SinaiUnited States Department of Defense; Department of Veterans Affairs, New JerseyCompletedGulf War IllnessUnited States
-
University at AlbanyUnited States Department of Defense; Women's College Hospital; The Sage Colleges and other collaboratorsCompleted
-
Boston University Charles River CampusUnknownGulf War IllnessUnited States
-
Roskamp Institute Inc.United States Department of Defense; Nova Southeastern UniversityRecruiting
-
Roskamp Institute Inc.United States Department of DefenseActive, not recruiting