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

NCT00810225 | Completed

• 3 other identifiers: 2008-012USAMRMC PR# W81XWH-07-1-0618HRPO Log No. A-14542.1
• Study Type: observational
• Target: 516
• Locations: 1 country
• Sites: 1

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.

Conditions

Gulf War Illness; Persian Gulf War Syndrome

Keywords

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

Study Arms (2)

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 Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgetown University: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (6)

• Gray GC, Reed RJ, Kaiser KS, Smith TC, Gastanaga 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. doi: 10.1093/aje/155.11.1033.

  PMID: 12034582 BACKGROUND

• 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. doi: 10.1186/1471-2377-5-22.

  PMID: 16321154 BACKGROUND

• 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, Koppel 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. doi: 10.2337/diabetes.54.8.2320.

  PMID: 16046297 BACKGROUND

• 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. doi: 10.1016/j.jchromb.2004.09.056.

  PMID: 15607706 BACKGROUND

• 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. doi: 10.1001/jama.280.11.981.

  PMID: 9749480 BACKGROUND

• 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.

  PMID: 33274349 DERIVED

Related Links

• Laboratory Website

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Persian Gulf Syndrome; Motor Activity; Fibromyalgia; Irritable Bowel Syndrome; Migraine Disorders; Multiple Chemical Sensitivity

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Behavior; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Environmental Illness; Hypersensitivity; Immune System Diseases; Disorders of Environmental Origin

Study Officials

• James N Baraniuk, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: June 18, 2018

Record last verified: 2018-06

Locations

US (1)