Interrogating Fatty Acid Metabolism Impairment and Clinical Correlates in Males with Klinefelter Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- maximal rate of fat oxidation
研究概览
简要总结
This study will learn more about how the body uses energy. Usually, the body uses sugars as energy first and then fats are used when the sugar stores are gone. Some people have trouble using fats as energy. This can lead to feeling tired, difficulty exercising, and storing too much fat where it does not belong (like in the muscle). It is believed that some boys and men with Klinefelter Syndrome may not be able to use fats as energy normally, and that a medication called fenofibrate could help this.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Ages 15 to 40 years
- •Total testosterone concentration within the normal range for age and pubertal stage
- •For the KS group only: genetic testing results confirming KS
排除标准
- •Liver disease (ALT or AST > 3x upper limit of normal)
- •Renal impairment (estimated creatinine clearance <80 ml/min)
- •Diabetes mellitus (A1c > 6.4%)
- •Untreated hypogonadism
- •Treatment with a PPAR agonist (including fish oil) or statin within the past month
- •Unstable medications with any medication added or removed within the past 2 weeks or plan for medication changes during the study period
- •Inability to tolerate study procedures, including any medical conditions that make exercise unsafe at the discretion of the study physician
- •For the KS group only: known allergy to fibrates, inability to swallow tablets
研究组 & 干预措施
Arm 2 (Interventional with cases)
Cases (those with Klinefelter); Comparison of outcomes pre and post fenofibrate intervention, 145mg PO daily for 4 weeks
干预措施: Fenofibrate 145 mg (Drug)
结局指标
主要结局
maximal rate of fat oxidation
时间窗: 1 month
maximal rate of fat oxidation during prolong submaximal exercise
skeletal muscle fat oxidation
时间窗: 1 month
Maximal skeletal muscle mitochondrial respiration with lipid substrate
次要结局
- differentially-expressed genes in plasma(1 month)
- differentially-expressed genes in skeletal muscle tissue(1 month)