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

• ClinicalTrials.gov Identifier: NCT00810225
• Recruitment Status: Completed
• First Posted: December 18, 2008
• Last Update Posted: June 18, 2018
• Sponsor: Georgetown University
• Collaborator: U.S. Army Medical Research and Development Command
• Information provided by (Responsible Party): James Baraniuk, MD, Georgetown University

Study Description

Brief Summary:

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 or disease
Gulf War Illness; Persian Gulf War Syndrome

Study Design

• Study Type: Observational
• Actual Enrollment: 516 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: CNDP1 Polymorphisms in Gulf War Illness (GWI)
• Study Start Date: August 2008
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: July 2011

Groups and Cohorts

Group/Cohort
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

Outcome Measures

Biospecimen Retention:   Samples With DNA

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• 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

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 Development Command

Investigators

• Principal Investigator: James N Baraniuk, MD; Georgetown University

More Information

Additional Information:

Laboratory Website 

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: James Baraniuk, MD, Professor of Medicine, Georgetown University
• ClinicalTrials.gov Identifier: NCT00810225
• Other Study ID Numbers: 2008-012; USAMRMC PR# W81XWH-07-1-0618; HRPO Log No. A-14542.1
• First Posted: December 18, 2008
• Last Update Posted: June 18, 2018
• Last Verified: June 2018

Keywords provided by James Baraniuk, MD, 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:

Syndrome; Persian Gulf Syndrome; Disease; Pathologic Processes; Occupational Diseases