Clinical trial NCT01264471: Mechanisms of Mitochondrial Defects in Gulf War Syndrome
Official title: Mechanisms of Mitochondrial Defects in Gulf War Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gulf War Syndrome
Mitochondrial Disease
Keywords: Gulf War Syndrome
Gulf War Illness
Mitochondrial defects
Mitochondrial disorders
Persian Gulf Syndrome
Lead sponsor: Medical Neurogenetics, LLC
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2010-12-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gulf War Veterans who have been diagnosed with Gulf War Syndrome

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Characterize mitochondrial cellular energetics in Gulf War Syndrome patients
timeFrame: approximately 2 years; once all data has been collected from study participants
Secondary outcomes:
measure: Mitochondrial DNA
timeFrame: approximately 2 years; once all data has been collected from study participants.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Medical Neurogenetics, LLC
state: Georgia
Study officials:
affiliation: Medical Neurogenetics
name: John M Shoffner, MD
role: PRINCIPAL_INVESTIGATOR
References: