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 SummaryCondition Keyword(s):
- Persian Gulf War
- Gulf War Syndrome
- Gulf War Illness
- Chronic Fatigue
- Irritable Bowel Syndrome
- Migraine headaches
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 TrialInclusion 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
- 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
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 InformationLead Sponsor: Georgetown University Other
Overall Clinical Trial Officials and ContactsJames N Baraniuk, MD Principal Investigator Georgetown University
Overall Contact: Yin Zheng, MS 202-687-8231 firstname.lastname@example.org
ReferencesGray 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 InformationInformation obtained from ClinicalTrials.gov on February 07, 2011
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01291758
Study ID Number: 2009-229
ClinicalTrials.gov Identifier: NCT01291758
Health Authority: United States: Institutional Review Board