Wednesday, February 9, 2011

DC Area Clinical Trial for Gulf War Veterans Now Recruiting Gulf War Veteran Paid Volunteers

Editor's note:  As of Feb. 1, 2012, recruitment is complete for this study.  No further study participants are being recruited.


The purpose of this study is to determine if submaximal exercise by bicycle stress tests with pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days causes a higher level of "exertional exhaustion" in GWI compared to healthy veterans (HVets)...
Date First Received: February 7, 2011
Last Updated: February 7, 2011
Verified by: Georgetown University, February 2011
Clinical Trial Phase: N/A | Start Date: July 2009
Overall Status: Recruiting
Estimated Enrollment: 80

Brief Summary
Condition Keyword(s):
Additional Keyword(s) Provided by Sponsor:
Condition MeSH Term(s), Assigned with an Experimental Algorithm:
The purpose of this study is to determine if submaximal exercise by bicycle stress tests with pulmonary measurement of VO2MAX plus maximal isometric hand grips on 2 consecutive days causes a higher level of "exertional exhaustion" in GWI compared to healthy veterans (HVets).
Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Cross-Sectional
Study Primary Completion Date: September 2012
Arms, Groups and Cohorts in this Clinical Trial
  • : GWI
    • Veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
  • : HC
    • Healthy veterans of the 1990-1991 Persian Gulf War
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 38 Years
Maximum Age for this Clinical Trial: 86 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Georgetown University Other
Overall Clinical Trial Officials and Contacts
James N Baraniuk, MD Principal Investigator Georgetown University  
Overall Contact: Yin Zheng, MS 202-687-8231
Related 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.
Additional Information
Information obtained from on February 07, 2011
Link to the current record.
Study ID Number: 2009-229 Identifier: NCT01291758
Health Authority: United States: Institutional Review Board
Laboratory Website

Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via and is not reviewed separately by Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

1 comment:

wes007 said...

Notice the wording to preclude some Gulf War Ill veterans from the trial.
As example I was on a sub in Desert Storm and Desert Shield my ship launched weapons in support of said action. However I would be precluded from this trial in the wording.
There are veterans that got sick before deploying and that did not serve in the so called waters of Gulf that did get sick with the same symptoms and many of the veterans now recoginzed with Gulf War Illness have forgotten that. Ironic when you consider when this first started the same government agency told all of you that you did not have it. So much for the concept of leaving no man or woman behind.