Identification of Gulf War Illness (GWI) Biomarkers

NCT03082638 | Completed

• 1 other identifier: RI-GWI-001
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gulf War Illness

Outcome Measures

Primary Outcomes (1)

• Lipid bio markers

  Determine if lipids specific to inflammation, mitochondria and peroxisome function can be objective biomarkers of the CNS pathology of GWI.

  2017 to 2019

Secondary Outcomes (1)

• Identification of Subgroups

  2017 to 2019

Study Arms (2)

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

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• 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 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.

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).
• 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

Sponsors & Collaborators

• Roskamp Institute Inc.: lead
• United States Department of Defense: collaborator

Study Sites (1)

The Roskamp Institute, Inc.

Sarasota, Florida, 34243, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

• Laila Abdullah, PhD

  The Roskamp Institute, Inc

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 17, 2017
• Study Start: January 18, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 17, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)