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临床试验/NCT00474396
NCT00474396已完成不适用

Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules

Icahn School of Medicine at Mount Sinai0 个研究点目标入组 59 人开始时间: 2005年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
主要终点
Lowering of serum uric acid levels

研究概览

简要总结

The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid levels.

详细描述

Uric acid plays a role not only in the pathogenesis of gout but is also a predictor of cardiovascular disease, hypertension and renal disease in man. We have identified the human urate ion channel transporter (hUAT), located in the proximal convoluted tubule of the kidney that is involved in both the secretion and reabsorption of urate across the tubule. This channel has a unique lectin binding site that in in-vitro studies, has been found to be modulated by glucose, galactose and lactose. We have also identified a mutation (G/A polymorphism) in our laboratory, that in in-vitro studies has demonstrated diminished hUAT channel activity. Cross-sectional studies have earlier shown that uric acid levels vary with serum glucose levels. Studies have also reported that a low-fat dairy diet reduces the incidence of gout, while others have shown that this diet reduces blood pressure significantly when compared with a non-dairy diet. We hypothesize that the effect of blood glucose levels in lowering uric acid levels is through the regulation of hUAT channel activity. We also hypothesize that a low-fat dairy diet reduces serum uric acid levels through hUAT regulation leading to a decrease in the incidence of gout and a reduction in blood pressure levels. In our proposed randomized, controlled, cross-over trial in healthy adult volunteers, we aim to study the effect of a low-fat dairy diet and a non-dairy diet on serum uric acid levels, the renal fractional excretion of uric acid and blood pressure. We will also study the effect of an acute intravenous infusion of glucose on these parameters. DNA analysis for hUAT mutations of study subjects will be done to assess if there is a blunted response of hUAT activity in subjects with the polymorphism as compared to normal individuals.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Healthy adult volunteers
  • Coronary artery disease
  • Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
  • Lactose intolerance
  • Milk allergy
  • Women who are pregnant or lactating
  • Subjects who are on any medications except birth control pills
  • Subjects who drink more than 3 servings of beer or liquor per week.
  • Normal blood pressure ( less than 120 mmHg systolic and 80 mmHg diastolic)
  • Normal serum UA levels
  • Normal renal funcion (calculated GFR >90ml/min)

排除标准

  • • Coronary artery disease
  • Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
  • Lactose intolerance
  • Milk allergy
  • Women who are pregnant or lactating
  • Subjects who are on any medications except birth control pills
  • Subjects who drink more than 3 servings of beer or liquor per week

结局指标

主要结局

Lowering of serum uric acid levels

次要结局

  • Lowering of the fractional excretion of uric acid and blood pressure

研究者

申办方类型
Other

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