Mechanisms of Mitochondrial Defects in Gulf War Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Characterize mitochondrial cellular energetics in Gulf War Syndrome patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Characterize mitochondrial cellular energetics in Gulf War Syndrome patients
时间窗: 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.
次要结局
- Mitochondrial DNA(approximately 2 years; once all data has been collected from study participants.)
研究者
John M. Shoffner
Medical Director
Medical Neurogenetics, LLC