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

This study has been completed.

Sponsor:

Collaborator:

U.S. Army Medical Research and Materiel Command

Information provided by (Responsible Party):

James Baraniuk, MD, Georgetown University

ClinicalTrials.gov Identifier:

NCT00810225

First received: December 17, 2008

Last updated: February 24, 2014

Last verified: February 2014

History of Changes

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:	Observational Model: Case Control Time Perspective: Cross-Sectional
Official Title:	CNDP1 Polymorphisms in Gulf War Illness (GWI)

Further study details as provided by Georgetown University:

Biospecimen Retention: Samples With DNA

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


Estimated Enrollment:	516
Study Start Date:	August 2008
Study Completion Date:	July 2011
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007

Sponsors and Collaborators

Georgetown University

U.S. Army Medical Research and Materiel Command

Investigators


Principal Investigator:	James N Baraniuk, MD	Georgetown University

More Information

Additional Information:

Laboratory Website This link exits the ClinicalTrials.gov site

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:	James Baraniuk, MD, Professor of Medicine, Georgetown University
ClinicalTrials.gov Identifier:	NCT00810225 History of Changes
Other 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:	February 24, 2014
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by Georgetown University:


CNDP1 carnosine dipeptidase 1 Persian Gulf War Gulf War Syndrome GWI Gulf War Illness Exercise	Chronic Fatigue Fibromyalgia Veterans Irritable Bowel Syndrome Migraine headaches Neuropathy Multiple Chemical Sensitivity

Additional relevant MeSH terms:


Persian Gulf Syndrome Occupational Diseases

ClinicalTrials.gov processed this record on March 01, 2015

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