Study of Gulf War Illness (GWI) by Comparing GWI and Healthy Veterans

NCT ID: NCT00810225

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

516 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-07-31

Brief Summary

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Determine if:

* genetic differences of CNDP1 gene
* the previously defined GWI/Chronic Fatigue Syndrome (GWI/CFS) cerebrospinal fluid proteome contents
* psychometric
* other variables can differentiate between veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms and those without these complaints.

Detailed Description

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Conditions

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Gulf War Illness Persian Gulf War Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

GWI: veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms

No interventions assigned to this group

2

HC: healthy veterans of the 1990-1991 Persian Gulf War

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Evidence of military enlistment between August 1, 1990 and July 31, 1991, and deployment for 30 consecutive days to:

* Persian Gulf waters and adjacent land areas
* Other global locations
* U.S. only
* Status prior to 1990 and 1991:

* Active duty
* National Guard
* Reserves

Exclusion Criteria

* Current active duty military personnel
* Any one who was not active duty military personnel between August 1, 1990 and July 31, 1991
* HIV/AIDS; pregnancy or lactation; potential hepatitis; drug addiction; chronic inflammatory, infectious, or autoimmune medical illnesses not associated with GWI; incarceration; dementia, other cognitive limitation; or reliance on a care-giver in order to respond to the questionnaires and other study tests.

Amputations of one or both hands and forearms will be permitted but hand grip tests will not be tested
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

Georgetown University

OTHER

Sponsor Role lead

Responsible Party

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James Baraniuk, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James N Baraniuk, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

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Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga VM. Self-reported symptoms and medical conditions among 11,868 Gulf War-era veterans: the Seabee Health Study. Am J Epidemiol. 2002 Jun 1;155(11):1033-44. doi: 10.1093/aje/155.11.1033.

Reference Type BACKGROUND
PMID: 12034582 (View on PubMed)

Baraniuk JN, Casado B, Maibach H, Clauw DJ, Pannell LK, Hess S S. A Chronic Fatigue Syndrome - related proteome in human cerebrospinal fluid. BMC Neurol. 2005 Dec 1;5:22. doi: 10.1186/1471-2377-5-22.

Reference Type BACKGROUND
PMID: 16321154 (View on PubMed)

Janssen B, Hohenadel D, Brinkkoetter P, Peters V, Rind N, Fischer C, Rychlik I, Cerna M, Romzova M, de Heer E, Baelde H, Bakker SJ, Zirie M, Rondeau E, Mathieson P, Saleem MA, Meyer J, Koppel H, Sauerhoefer S, Bartram CR, Nawroth P, Hammes HP, Yard BA, Zschocke J, van der Woude FJ. Carnosine as a protective factor in diabetic nephropathy: association with a leucine repeat of the carnosinase gene CNDP1. Diabetes. 2005 Aug;54(8):2320-7. doi: 10.2337/diabetes.54.8.2320.

Reference Type BACKGROUND
PMID: 16046297 (View on PubMed)

Casado B, Zanone C, Annovazzi L, Iadarola P, Whalen G, Baraniuk JN. Urinary electrophoretic profiles from chronic fatigue syndrome and chronic fatigue syndrome/fibromyalgia patients: a pilot study for achieving their normalization. J Chromatogr B Analyt Technol Biomed Life Sci. 2005 Jan 5;814(1):43-51. doi: 10.1016/j.jchromb.2004.09.056.

Reference Type BACKGROUND
PMID: 15607706 (View on PubMed)

Fukuda K, Nisenbaum R, Stewart G, Thompson WW, Robin L, Washko RM, Noah DL, Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC. Chronic multisymptom illness affecting Air Force veterans of the Gulf War. JAMA. 1998 Sep 16;280(11):981-8. doi: 10.1001/jama.280.11.981.

Reference Type BACKGROUND
PMID: 9749480 (View on PubMed)

Narayan V, Shivapurkar N, Baraniuk JN. Informatics Inference of Exercise-Induced Modulation of Brain Pathways Based on Cerebrospinal Fluid Micro-RNAs in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Netw Syst Med. 2020 Nov 18;3(1):142-158. doi: 10.1089/nsm.2019.0009. eCollection 2020.

Reference Type DERIVED
PMID: 33274349 (View on PubMed)

Related Links

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Other Identifiers

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USAMRMC PR# W81XWH-07-1-0618

Identifier Type: -

Identifier Source: secondary_id

HRPO Log No. A-14542.1

Identifier Type: -

Identifier Source: secondary_id

2008-012

Identifier Type: -

Identifier Source: org_study_id

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