Expired Study
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Washington, District of Columbia 20007


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.


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


Study is Available At:


Original ID:

2008-012


NCT ID:

NCT00810225


Secondary ID:

USAMRMC PR# W81XWH-07-1-0


Study Acronym:


Brief Title:

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


Official Title:

CNDP1 Polymorphisms in Gulf War Illness (GWI)


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Georgetown University


Oversight Authority:

  • United States: Institutional Review Board
  • United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

516


Enrollment Type:

Actual


Overall Contact Information

Official Name:James N Baraniuk, MD
Principal Investigator
Georgetown University

Study Dates

Start Date:August 2008
Completion Date:July 2011
Completion Type:Actual
Primary Completion Date:July 2011
Primary Completion Type:Actual
Verification Date:June 2018
Last Changed Date:June 15, 2018
First Received Date:December 17, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:1
Description:GWI: veterans of the 1990-1991 Persian Gulf War who have autonomic, neurological and other symptoms
Study Arm Type:Other
Arm Name:2
Description:HC: healthy veterans of the 1990-1991 Persian Gulf War

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Georgetown University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:U.S. Army Medical Research and Materiel Command

Samples and Retentions

Sample Retention:Samples With DNA
Description: Plasma, serum, urine, and buccal swab samples retained for testing as described in protocol.
Study Population: All veterans who served in the Armed Forces between August 1990 and July 1991
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:12034582
Reference Type:Reference
Citation: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.
PMID:16321154
Reference Type:Reference
Citation: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.
PMID:16046297
Reference Type:Reference
Citation: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.
PMID:15607706
Reference Type:Reference
Citation: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.
PMID:9749480

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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