Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum GDF-15
研究概览
简要总结
The purpose of this study is to develop simple diagnostic screeningtests and investigate potential biomarkers for identifying patients with abnormalities of mitochondrial function, which also can be used as outcome measures in future clinical trials. The study will investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with mitochondrial myopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-75
- •verified mitochondrial myopathy
- •or healthy control
- •or disease control (another neuromuscular disease)
排除标准
- •Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
- •Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction
- •Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Serum GDF-15
时间窗: 1 hour
Changes between: before and after exercise, fasted and fed.
Serum lactate / pyruvate ratio
时间窗: 1 hour
Changes between: before, during and after submaximal exercise
Serum Acyl-carnitine levels
时间窗: 1 hour
Changes between: before and after exercise, fasted and fed.
次要结局
未报告次要终点
研究者
Nicoline Løkken
MD, PhD-student
Rigshospitalet, Denmark