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
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Condition or disease | Intervention/treatment |
---|---|
Gulf War Syndrome Mitochondrial Disease | Procedure: Skin biopsy Procedure: Blood Collection |
Study Type : | Observational |
Actual Enrollment : | 26 participants |
Observational Model: | Case-Only |
Time Perspective: | Cross-Sectional |
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 |

Group/Cohort | Intervention/treatment |
---|---|
Gulf War Syndrome patients
Gulf War veterans who have been diagnosed with Gulf War Syndrome.
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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 sample
Procedure: Blood Collection
Approximately 45ml or 3 tablespoons for blood will be drawn from a vein in the patient's forearm.
Other Names:
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- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Short-term memory loss or a severe inability to concentrate that affects work, school or other normal activities
- Muscle Pain, myalgias
- Pain without redness or swelling in a number of joints
- Intense or changing patterns of headaches
- Unrefreshing sleep
- After any exertion, weariness that lasts for more than a day
Exclusion Criteria:
- Organ failure (e.g. emphysema, cirrhosis, cardiac failure, chronic renal failure)
- Chronic infections (e.g. HIV/AIDS, hepatitis B or C)
- Rheumatic and chronic inflammatory diseases (e.g. systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis.)
- Major neurologic diseases (e.g. multiple sclerosis, neuromuscular diseases, epilepsy or other disease requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
- Diseases requiring systemic treatment (e.g. organ or bone marrow transplantation; systemic chemotherapy; radiation of brain, thorax, abdomen, or pelvis)
- Major endocrine diseases (e.g. hypopituitarism, adrenal insufficiency)
- Myocardial infarction, heart failure
- Morbid obesity (body mass index >40)
- Permanent psychiatric exclusions: Lifetime diagnoses of bipolar affective disorders, schizophrenia or any subtype, delusional disorders of any subtype, dementias of any subtype, organic brain disorders, and alcohol or substance abuse within 2 years before onset of the fatiguing illness.
- History of allergic reaction to lidocaine
- History of keloid formation with skin incisions.

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 |
Responsible Party: | John M. Shoffner, Medical Director, Medical Neurogenetics, LLC |
ClinicalTrials.gov Identifier: | NCT01264471 History of Changes |
Other Study ID Numbers: |
H09378 GW080138 ( Other Grant/Funding Number: Department of Defense CDMRP ) |
First Posted: | December 21, 2010 Key Record Dates |
Last Update Posted: | April 13, 2015 |
Last Verified: | April 2015 |
Keywords provided by John M. Shoffner, Medical Neurogenetics, LLC:
Gulf War Syndrome Gulf War Illness Mitochondrial defects Mitochondrial disorders Persian Gulf Syndrome |
Additional relevant MeSH terms:
Syndrome Mitochondrial Diseases Persian Gulf Syndrome Disease |
Pathologic Processes Metabolic Diseases Occupational Diseases |