Validating Gulf War Illness Blood Biomarkers

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05736146
Study type	Observational
Source	Roskamp Institute Inc.
Contact	Dakota Helgager, B.S
Phone	(941) - 256 - 8019
Email	dhelgager@roskampclinic.org
Status	Recruiting
Phase
Start date	June 30, 2022
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT02011542` - Probiotic (VSL #3) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT03078530` - Probiotic (Visbiome) for Gulf War Illness	Phase 2/Phase 3
Recruiting	`NCT04058275` - "Immunomodulation in GWI (Phlebotomy)"
Recruiting	`NCT04255498` - Understanding GWI: Integrative Modeling	Phase 1
Completed	`NCT02782780` - Cognitive Behavioral Therapy for Insomnia for Gulf War Illness	N/A
Recruiting	`NCT02983734` - D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)	Phase 2
Recruiting	`NCT05972291` - Mechanisms of Gulf War Illness	N/A
Recruiting	`NCT04182659` - Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms	N/A
Recruiting	`NCT04046536` - rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)	N/A
Recruiting	`NCT05675878` - Confirmation of Diet as a Treatment for Gulf War Illness	Phase 3
Not yet recruiting	`NCT05820893` - Resistant Potato Starch to Alleviate GWI	Phase 2
Terminated	`NCT01846182` - Research Examining Gulf War Illness in Our Nations Service Members	Phase 2
Active, not recruiting	`NCT05252949` - OEA for Targeting Lipid Metabolism in GWI	N/A
Completed	`NCT02378025` - Treating Chronic Pain in Gulf War Illness	N/A
Completed	`NCT02865460` - Coenzyme Q10 Phase III Trial in Gulf War Illness	Phase 3
Completed	`NCT02909686` - Effects of Botanical Microglia Modulators in Gulf War Illness	N/A
Completed	`NCT01291758` - Exercise in Gulf War Illness (GWI)
Completed	`NCT01011348` - Q10 for Gulf War Veterans	N/A
Completed	`NCT00810329` - Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.