Study of Gulf War Illness (GWI) by Comparing GWI and Healthy Veterans - Full Text View

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

This study is currently recruiting participants.

Verified by Georgetown University, July 2009

First Received: December 17, 2008 Last Updated: July 2, 2009 History of Changes

Sponsors and Collaborators:	Georgetown University U.S. Army Medical Research and Materiel Command
Information provided by:	Georgetown University
ClinicalTrials.gov Identifier:	NCT00810225

Purpose

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.

Condition
Gulf War Illness Persian Gulf War Syndrome

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	CNDP1 Polymorphisms in Gulf War Illness (GWI)

Further study details as provided by Georgetown University:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Plasma, serum, urine, and buccal swab samples retained for testing as described in protocol.

Estimated Enrollment:	516
Study Start Date:	August 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 GWI: veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
2 HC: healthy veterans of the 1990-1991 Persian Gulf War

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

All veterans who served in the Armed Forces between August 1990 and July 1991

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810225

Contacts

Contact: Yin Zheng	202-687-8231	gwiresearch@georgetown.edu
Contact: Murugan K Ravindran, MD	202-687-8231	gwiresearch@georgetown.edu

Locations

United States, District of Columbia
Georgetown University	Recruiting
Washington, District of Columbia, United States, 20007
Contact: Samantha J Merck 202-687-8231 gwiresearch@georgetown.edu
Principal Investigator: James N Baraniuk, MD

Sponsors and Collaborators

Georgetown University

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:

James N Baraniuk, MD

Georgetown University

More Information

Publications:

Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastañaga 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. Erratum in: Am J Epidemiol. 2005 Feb 1;161(3):302.

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.

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, Köppel 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.

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.

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.

Responsible Party:	Georgetown University ( James N. Baraniuk, MD )
Study ID Numbers:	2008-012, USAMRMC PR# W81XWH-07-1-0618, HRPO Log No. A-14542.1
Study First Received:	December 17, 2008
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00810225 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by Georgetown University:

CNDP1
carnosine dipeptidase 1
GWI
Gulf War Illness

Study placed in the following topic categories:

Disorders of Environmental Origin
Occupational Diseases
Healthy
Persian Gulf Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

Disorders of Environmental Origin
Occupational Diseases
Persian Gulf Syndrome

ClinicalTrials.gov processed this record on September 03, 2009