[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05736146":3,"trial-entities:NCT05736146":126,"trial-summary:NCT05736146":130},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":31,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":25,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":109,"overall_officials":113,"references":121,"see_also_links":122},"NCT05736146","RI-GWI-003","Validating Gulf War Illness Blood Biomarkers","Validating Blood Biomarkers of Brain Immune and Metabolic Dysfunction in Gulf War Illness","RECRUITING","2026-03-01","2024-11","2025-07-24","2022-06-30","Roskamp Institute Inc.","OTHER",false,"The investigators goals are to identify blood lipids\u002Fmetabolites 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\u002Fmetabolite 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\u002Fmetabolites that correlate with the CNS dysfunction in GWI.","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\u002Fmetabolite 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\u002Fmetabolites 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.",[19,20],"Gulf War Syndrome","Gulf War Illness",[22,23],"Gulf War","APOE","OBSERVATIONAL",null,[],{"count":28,"type":29},100,"ESTIMATED",[],[32,36,39,42],{"measure":33,"description":34,"timeFrame":35},"Validate Blood Biomarkers","To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids\u002Fmetabolites that correlate with the CNS dysfunction in GWI.","2022-2024",{"measure":37,"description":38,"timeFrame":35},"Identify Blood\u002FLipid Profiles","To identify blood lipid\u002Fmetabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI.",{"measure":40,"description":41,"timeFrame":35},"Effect of Dietary, Medical and Biological Factors","To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans.",{"measure":43,"description":44,"timeFrame":35},"Metabolites Correlating with Cognitive Decline","To identify blood lipids\u002Fmetabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI.",[],"ALL","35 Years",true,{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"Inclusion Criteria:\n\n1. Age 35 years or older.\n2. 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.\n3. For controls, must be a veteran in the same age range as those veterans with GWI as defined above.\n4. Ability to understand written and spoken English or availability of a legal representative who can understand written or spoken English. Participants and caregiver\u002Finformants 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.\n\nExclusion Criteria:\n\n1. 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:\n\n   1. Cancer (except for non-melanoma skin cancers)\n   2. Chronic infectious disease\n   3. Problems resulting from postwar injuries.\n   4. Liver disease\n   5. Lupus\n   6. Multiple sclerosis\n   7. Stroke\n   8. Serious psychiatric condition (those associated with psychosis and\u002For for which the respondent had been hospitalized since 1991).\n   9. Dementia or any type of Parkinson's disease (PD).\n2. Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD).\n3. Female subject is either pregnant or nursing.",[54,55],"ADULT","OLDER_ADULT",[57,75,94],{"facility":58,"status":8,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":72},"Palto Alto Veterans Institute for Research","Palo Alto","California","94304","United States",[64,69],{"name":65,"role":66,"phone":67,"email":68},"Raj Brar","CONTACT","650-374-9073","RBrar@pavir.org",{"name":70,"role":71},"Maheen Adamson, Ph.D","SUB_INVESTIGATOR",{"lat":73,"lon":74},37.44188,-122.14302,{"facility":76,"status":8,"city":77,"state":78,"zip":79,"country":62,"contacts":80,"geoPoint":91},"The Roskamp Institute","Sarasota","Florida","34232",[81,86,89],{"name":82,"role":66,"phone":83,"phoneExt":84,"email":85},"Dakota M Helgager, B.S.","941-256-8019","3008","dhelgager@roskampclinic.org",{"name":87,"role":88},"Laila Abdullah, Ph.D","PRINCIPAL_INVESTIGATOR",{"name":90,"role":71},"Michael Hoffmann, MD",{"lat":92,"lon":93},27.33643,-82.53065,{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":62,"contacts":99,"geoPoint":106},"Boston University","Boston","Massachusetts","02118",[100,104],{"name":101,"role":66,"phone":102,"email":103},"Leah Orlinsky","617-358-2214","bbrain@bu.edu",{"name":105,"role":71},"Kim Sullivan, Ph.D",{"lat":107,"lon":108},42.35843,-71.05977,[110],{"name":111,"role":66,"phone":112,"phoneExt":84,"email":85},"Dakota Helgager, B.S","(941) - 256 - 8019",[114,116,117,118],{"name":115,"affiliation":76,"role":88},"Laila Abdullah, Ph.D.",{"name":90,"affiliation":76,"role":88},{"name":105,"affiliation":95,"role":88},{"name":119,"affiliation":120,"role":88},"Maheen Adamson, Ph.D.","Palo Alto Veterans Institute of Research",[],[123],{"label":124,"url":125},"The Roskamp Institute Home Page","http:\u002F\u002Fwww.roskampinstitute.org\u002F",{"nct_id":4,"conditions":127,"biomarkers":129},[128],"Gulf war syndrome",[],{"nct_id":4,"found":48,"summary":131,"prompt_version":141},{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This is an observational study planning to enroll 100 participants. It is not testing a new treatment but rather observing and collecting information.","completed","Validating Blood Biomarkers for Gulf War Illness","This observational study is looking for ways to better understand Gulf War Illness (GWI). Researchers are studying blood samples from veterans to find specific markers (biomarkers) that might be linked to GWI and its effects on the brain. They want to identify patterns in blood fats (lipids) and other substances that could explain cognitive decline and energy problems often seen in GWI. The study will also explore how diet, medical history, and other biological factors might influence these blood markers. This research aims to validate these blood markers to help with diagnosis and understanding GWI. The study plans to enroll 100 participants, including veterans aged 35 or older who meet the criteria for GWI, and control veterans in the same age range.","The primary endpoints, including validating blood biomarkers and identifying blood\u002Flipid profiles, will be measured between 2022 and 2024.",122,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]