Validating Gulf War Illness Blood Biomarkers

NCT05736146 | Recruiting

• 1 other identifier: RI-GWI-003
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Gulf War Syndrome; Gulf War Illness

Keywords

Gulf War; APOE

Outcome Measures

Primary Outcomes (4)

• Validate Blood Biomarkers

  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

  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

  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

  To identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI.

  2022-2024

Study Arms (2)

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.

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Veterans who served in the Gulf War during 1990 to 1991.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Roskamp Institute Inc.: lead
• Boston University: collaborator
• Palo Alto Veterans Institute for Research: collaborator
• United States Department of Defense: collaborator

Study Sites (3)

Palto Alto Veterans Institute for Research

Palo Alto, California, 94304, United States

RECRUITING

The Roskamp Institute

Sarasota, Florida, 34232, United States

RECRUITING

Boston University

Boston, Massachusetts, 02118, United States

RECRUITING

Related Links

• The Roskamp Institute Home Page

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be analyzed for lipids, proteins, DNA, RNA and breakdown products to identify biomarkers for GWI.

MeSH Terms

Conditions

Persian Gulf Syndrome

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries

Study Officials

• Laila Abdullah, Ph.D.

  The Roskamp Institute

  PRINCIPAL INVESTIGATOR

• Michael Hoffmann, MD

  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

Central Study Contacts

Dakota Helgager, B.S

CONTACT

(941) - 256 - 8019; dhelgager@roskampclinic.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: June 30, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)