NCT03293615终止不适用
Exercise Capacity of Patients with Dermatomyosisthe Role of Muscle Mitochondria and Reactive Oxygen Species
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年11月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.
研究概览
简要总结
Dermatomyositis (DM) patients experience muscle weakness and low aerobic capacities, which are associated with poor health status and increased mortality. The origin of this muscle impairment remains unknown.
The investigators hypothesize that mitochondria functioning is impaired in DM muscle and links with exercise capacities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Woman or man> 18 years,
- •Signature of informed consent,
- •Muscle biopsy for suspicion of recent inflammatory myopathy (<6 months) or for exclusion of neuromuscular pathology.
- •Prospectively, following the results of the muscle biopsy, the subjects will divided into three groups meeting the following criteria:
- •"DM" group: DM according to the ENMC criteria;
- •"other inflammatory myopathy" group: polymyositis, autoimmune necrotizing myopathy, non-specific myositis or inclusion myositis according to the ENMC criteria;
- •Group "no neuromuscular pathology": i) myalgia and / or intolerance to exercise and ii) normal neuromuscular examination, iii) no increase in blood creatine kinase level, iv) absence of electromyographic abnormality, v) histological Muscle mass.
排除标准
- •- Taking an immunomodulatory treatment within 6 months before inclusion,
- •Paraneoplastic form of the disease,
- •Presence of associated interstitial pneumonitis,
- •Neuromuscular pathology different from inflammatory myopathy,
- •Unbalanced cardiovascular disease,
- •Impossibility of giving the subject informed information (subject in an emergency situation, difficulty in understanding the subject, ...),
- •Subject under safeguard of justice,
- •Subject under tutelage or under curators,
- •Pregnancy (positive pregnancy test)
- •Breastfeeding.
结局指标
主要结局
Difference in the capacity of muscle fibers to consume oxygen in the muscle of patients i) with DM, ii) with other inflammatory myopathy, iii) without neuromuscular disease.
时间窗: Baseline
This difference in mitochondrial breathing capacity in the muscle will be achieved by: Muscle biopsy
次要结局
未报告次要终点
研究者
研究点 (2)
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