Obesity and Endogenous Oxalate Synthesis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Urinary Oxalate Excretion
研究概览
简要总结
The goal of this study is to determine if obesity is associated with increased endogenous oxalate synthesis as assessed by urinary oxalate excretion, which is a known risk factor for calcium oxalate kidney stones.
The study will recruit adult participants without history of kidney stones. Participants will
- Ingest fixed diets containing low amounts of oxalate for 4 days
- Collect 24-hr urine samples during the fixed diet
详细描述
In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, in individuals of varying body sizes without history of kidney stones. The 24-hr urinary oxalate excretion on such a low-oxalate normal calcium fixed diet is determined to be an appropriate surrogate for endogenous oxalate synthesis.
Screening phase. The study will enroll 60 individuals without history of kidney stones (30 males/30 females) at the University of Alabama at Birmingham (UAB).
Screening will include blood complete metabolic profile, 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements.
Dietary phase Participants will ingest a low-oxalate (<60 mg/day), normal calcium (1000 mg/day) fixed diet for 4 consecutive days, collect three 24-hr urines after 1 day of dietary equilibration and have a fasted blood draw on day 5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19-70 yrs Body Mass Index > 18.5 kg/m2 Normal fasting serum electrolytes on comprehensive metabolic profile Willing to ingest fixed diets
排除标准
- •Chronic Kidney Disease, estimated glomerular filtration rate < 60 ml/mn/1.73m2 Primary hyperoxaluria Liver, endocrine or renal diseases or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion Pregnancy or breast-feeding Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus Active malignancy or treatment for malignancy within 12 months prior to screening Utilization of immunosuppressive medication Uncontrolled Hypertension or diabetes
研究组 & 干预措施
Normal Individuals
Normal individuals: no prior history of kidney stones
干预措施: Normal Individuals (Dietary Supplement)
结局指标
主要结局
Urinary Oxalate Excretion
时间窗: 3 days on the fixed diet
Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day)
次要结局
- Urinary Glycolate Excretion(3 days on fixed diet)
- Urinary Creatinine Excretion(3 days on the fixed diet)
研究者
Kyle D. Wood
Principal Investigator
University of Alabama at Birmingham