Mechanisms of Mitochondrial Defects in Gulf War Syndrome
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|ClinicalTrials.gov Identifier: NCT01264471|
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : April 13, 2015
|Condition or disease||Intervention/treatment|
|Gulf War Syndrome Mitochondrial Disease||Procedure: Skin biopsy Procedure: Blood Collection|
|Study Type :||Observational|
|Actual Enrollment :||26 participants|
|Official Title:||Mechanisms of Mitochondrial Defects in Gulf War Syndrome|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Gulf War Syndrome patients
Gulf War veterans who have been diagnosed with Gulf War Syndrome.
Procedure: Skin biopsy
A small skin sample will be obtained from the patients arm which is approximately the size of the top of a thumbtack (a small circle no more than a 1/4 inch across)
Other Name: skin sampleProcedure: Blood Collection
Approximately 45ml or 3 tablespoons for blood will be drawn from a vein in the patient's forearm.
- Characterize mitochondrial cellular energetics in Gulf War Syndrome patients [ Time Frame: approximately 2 years; once all data has been collected from study participants ]After collecting a skin and blood sample, mitochondrial cellular energetics in Gulf War Syndrome patients will be characterized by: 1. high resolution respirometry of intact cells, 2. quantitative analysis of individual mitochondrial proteins, 3. analysis of intact OXPHOS enzyme complexes and supercomplexes, 4. in gel enzyme activity assessment of intact OXPHOS enzyme complexes and supercomplexes, 5. mitochondrial DNA (mtDNA) copy number quantitation to assess for defects in regulation mtDNA replication and 6. cellular coenzyme Q10 quantitation.
- Mitochondrial DNA [ Time Frame: approximately 2 years; once all data has been collected from study participants. ]Assess the mitochondrial DNA (mtDNA) from each patient with Gulf War Syndrome for mtDNA mutations by whole genome sequencing of leukocyte and skin cell mtDNA.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264471
|United States, Georgia|
|Medical Neurogenetics, LLC|
|Atlanta, Georgia, United States, 30342|
|Principal Investigator:||John M Shoffner, MD||Medical Neurogenetics|