- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05736146
Validating Gulf War Illness Blood Biomarkers
January 24, 2024 updated by: Roskamp Institute Inc.
Validating Blood Biomarkers of Brain Immune and Metabolic Dysfunction in Gulf War Illness
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI.
To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans.
To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI.
To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Nearly 30 years later, veterans with Gulf War Illness (GWI) continue to suffer from this persistent and debilitating illness, which remains difficult to diagnose due to the heterogeneity of clinical presentation and the complexity of biological responses to hazardous chemicals to which GW veterans were exposed during the 1990-1991 Gulf War (GW).
Brain imaging studies of veterans with GWI and pre-clinical animal studies of rodents with GWI show that impaired bioenergetics and inflammation can be attributed to the atrophy of the axonal white matter tracts that link the cortical gray matter regions, and the alterations of lipid/metabolite levels.
The investigators recent work shows that disturbed lipid profiles in the brain and blood after GW pesticide exposure in rodents accompany neurobehavioral and bioenergetics deficits and inflammation.
The mechanisms of neurotoxicity after pesticide exposure include increases in the inactivation of lipid metabolizing enzymes.
This may consequently result in accumulation of lipids in the body compartments that limit their availability for use as energy substrates, contributing to bioenergetic impairments and inflammation.
These metabolic changes have also been linked to individuals who possess the apolipoprotein E (APOE) ε4 allele, a risk factor of aging related cognitive decline and neurodegenerative conditions, such as Alzheimer's disease (AD).
Several studies have shown a correlation between lipid transport deficits and presence of the ε4 allele.
The identification of specific lipids/metabolites and the APOE ε4 allele as important biomarkers of GWI would serve to objectively assess the brain pathology of GWI and identify subgroups of GWI based on symptom patterns and GW exposures.
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dakota Helgager, B.S
- Phone Number: 3008 (941) - 256 - 8019
- Email: dhelgager@roskampclinic.org
Study Locations
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California
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Palo Alto, California, United States, 94304
- Recruiting
- Palto Alto Veterans Institute for Research
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Contact:
- Raj Brar
- Phone Number: 650-374-9073
- Email: RBrar@pavir.org
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Sub-Investigator:
- Maheen Adamson, Ph.D
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Florida
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Sarasota, Florida, United States, 34232
- Recruiting
- The Roskamp Institute
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Sub-Investigator:
- Michael Hoffmann, MD
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Contact:
- Dakota M Helgager, B.S.
- Phone Number: 3008 941-256-8019
- Email: dhelgager@roskampclinic.org
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Principal Investigator:
- Laila Abdullah, Ph.D
-
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Recruiting
- Boston University
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Sub-Investigator:
- Kim Sullivan, Ph.D
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Contact:
- Leah Orlinsky
- Phone Number: 617-358-2214
- Email: bbrain@bu.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Veterans who served in the Gulf War during 1990 to 1991.
Description
Inclusion Criteria:
- Age 35 years or older.
- For GWI cases, served in the 1990-1991 Gulf War as active duty, national guard, or reserves and meet criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition.
- For controls, must be a veteran in the same age range as those veterans with GWI as defined above.
- 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).
- Dementia or any type of Parkinson's disease (PD).
- Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).
- Female subject is either pregnant or nursing.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Case: GWI
This group includes participants who served in the Gulf War during 1990 -1991 and have Gulf War Illness based on either the Kansas or CDC symptom criteria.
|
Control
This group includes participants who served in the Gulf War during 1990 -1991 and have no symptoms of Gulf War Illness based on both the Kansas and CDC symptom criteria.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validate Blood Biomarkers
Time Frame: 2022-2024
|
To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
|
2022-2024
|
Identify Blood/Lipid Profiles
Time Frame: 2022-2024
|
To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI.
|
2022-2024
|
Effect of Dietary, Medical and Biological Factors
Time Frame: 2022-2024
|
To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans.
|
2022-2024
|
Metabolites Correlating with Cognitive Decline
Time Frame: 2022-2024
|
To identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI.
|
2022-2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laila Abdullah, Ph.D., The Roskamp Institute
- Principal Investigator: Kim Sullivan, Ph.D, Boston University
- Principal Investigator: Maheen Adamson, Ph.D., Palo Alto Veterans Institute of Research
- Principal Investigator: Michael Hoffmann, MD, The Roskamp Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2022
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
February 9, 2023
First Submitted That Met QC Criteria
February 9, 2023
First Posted (Actual)
February 21, 2023
Study Record Updates
Last Update Posted (Estimated)
January 25, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RI-GWI-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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