Non Alcoholic Fatty Liver Disease and Endogenous Oxalate Synthesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- estimated 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 fasted urine collection and a low-oxalate controlled diet in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
详细描述
Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use a low-oxalate controlled diet, repeat fasted urine collections and 24-hr urine collections on a low-oxalate diet, to determine the daily rate of endogenous oxalate synthesis in individuals with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years
- •History of MASLD, with liver fat content > 5%
- •Normal kidney function
- •Stable medication for at least 1 month for diabetes mellitus if any
- •Willingess to ingest fixed diets and stop dietary supplements for the study and come to UAB for visits
排除标准
- •Age < 18 years
- •Inaccurate 24-hour urine collections
- •Liver fat content <5%
- •Liver cirrhosis
- •Evidence of other chronic liver disease, viral hepatitis
- •history of alcoholism within 2 years of enrollment
- •Contra-indication to Magnetic Resonance Imaging
- •Chronic kidney disease with estimated Glomerular Filtration rate < 60 ml/min/1.73m2
- •Type 1 Diabetes Mellitus or treatment with insulin
- •Uncontrolled diabetes
- •Pregnancy, lactation or intention to be
- •Uncontrolled hypertension
- •Use of weight loss medication, SGLT2 inhibitors, GLP-1 receptor agonists, osteoporosis medication, chronic NSAID
- •History of gastric or intestinal surgery or resection that could potentially alter oxalate absorption
- •Chronic fat malabsorption
- •Use of immunosuppressive medications
- •Known immuno-compromised status
- •Active malignancy or treatment for malignanacy within the last 12 months
研究组 & 干预措施
Estimation of endogenous oxalate production
Fasted hourly urine collections after equilibration on a low-oxalate diet
干预措施: Low-oxalate fixed diet (Dietary Supplement)
结局指标
主要结局
estimated endogenous oxalate synthesis rate
时间窗: 1 day
Average fasted hourly urinary oxalate excretion rate normalized to urinary creatinine excretion (mg oxalate / g urinary creatinine)
次要结局
- Urinary Oxalate excretion(2 days)
研究者
Kyle D. Wood
Principal Investigator
University of Alabama at Birmingham