An observational study in Gulf War Syndrome and Mitochondrial Disease, sponsored by Medical Neurogenetics, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-13.
Sponsored by Medical Neurogenetics, LLC · Observational
The purpose of the study is to investigate possible causes for Gulf War Syndrome. Gulf War Syndrome is associated with increased incidences of amyotrophic lateral sclerosis (Lou Gehrig's Disease), pain syndromes, muscle complaints that include fatigue and myalgias (muscle pain), as well as other neurological symptoms. Abnormalities in the part of the cell known as mitochondria have been delineated in Gulf War Syndrome. Mitochondria are the "power plants" of the body. Mitochondria take the food you eat and break the food down into a form of energy that the body can use. The investigators propose that Gulf War Syndrome is determined by a complex interaction of factors that interfere with mitochondrial function. This study will be the first investigation of mitochondrial function in Gulf War Syndrome. The investigators objective is to establish the cause for symptoms in affected veterans, develop testing that can more easily identify Gulf War Syndrome, and ultimately develop treatment protocols for Gulf War Syndrome.
182 studies on the registry are indexed under Mitochondrial Diseases; 54 are open to participants now.
This study's enrollment of 26 is below the median of 60 across 72 observational studies indexed under Mitochondrial Diseases.
Browse Mitochondrial Diseases studies →This is the only study on the registry with Medical Neurogenetics, LLC as lead sponsor.
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Gulf War Veterans who have been diagnosed with Gulf War Syndrome
Exclusion Criteria:
Gulf War veterans who have been diagnosed with Gulf War Syndrome.
Procedure: Skin biopsy · Procedure: Blood Collection
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)
Also known as: skin sample
Approximately 45ml or 3 tablespoons for blood will be drawn from a vein in the patient's forearm.
Also known as: phlebotomy, blood draw
Characterize mitochondrial cellular energetics in Gulf War Syndrome patients
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.
Time frame: approximately 2 years; once all data has been collected from study participants
Mitochondrial DNA
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.
Time frame: approximately 2 years; once all data has been collected from study participants.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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