Assessment of Endogenous Oxalate Synthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Endogenous Oxalate Synthesis Rate
研究概览
简要总结
This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet.
详细描述
Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use low-oxalate controlled diet and intravenous infusion of the isotope tracer carbon 13 oxalate, timed with blood and urine collections, to determine the daily rate of endogenous oxalate synthesis in non-stone forming volunteers and in subjects with calcium oxalate kidney stones. A DXA scan will be used to assess body composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
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
- •Mentally competent adults, able to read and comprehend the consent form
- •Body Mass Index (BMI) between 18.5 and 50 kg/m2
- •Acceptable 24 hour urine collections (judged on screening)
- •good health as judged from a medical history, reported medications, and a complete blood metabolic profile
- •with or without history of calcium oxalate kidney stones
排除标准
- •History of any hepatic, bowel, or endocrine disease or other condition that may influence the absorption, transport or urine excretion of ions
- •Abnormal urine chemistries or blood metabolic profiles
- •Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
- •Pregnancy, intention to become pregnant in the near future, or lactation
- •Aged lower than 18 or greater than 75 years
- •BMI lower than18.5 or greater than 50 kg/m2
结局指标
主要结局
Endogenous Oxalate Synthesis Rate
时间窗: day 5
Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method
次要结局
- Urinary Oxalate Excretion(day 3-4)
- Urinary Creatinine Excretion(day 3-4)
研究者
Sonia Fargue
Assistant Professor
University of Alabama at Birmingham