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临床试验/NCT00904046
NCT00904046已完成不适用

Pathophysiology of Uric Acid Nephrolithiasis

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2010年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
Reversal of renal lipotoxicity will occur with pioglitazone.

研究概览

简要总结

This study has two aims:

Aim 1: To determine the presence of accumulation of fat within cells and the functional consequences of this in the kidney by correlating kidney fat content with urine test results.

Aim 2: The investigators will evaluate the effect of thiazolidinedione (pioglitazone) on excess fatty acid accumulation in kidney tissue and its correlation with uric acid stone formation in subjects with uric acid stones.

Pioglitazone is already U.S. Food & Drug Administration (FDA)-approved for the treatment of type 2 diabetes, but is not approved by the FDA for treating or preventing or diagnosing stone risk.

详细描述

The study will use a combination of cell culture, animal, and human studies employing some of the latest technologies in magnetic resonance spectroscopy and single-photon emission computed tomography, combined with classical physiology, biochemistry, and molecular biology to test four interrelated hypotheses. There is increased uptake of free fatty acids into the kidney as a result of higher circulating levels as well as preferential transport by the proximal tubule as part of a "conditioning" effect. The increased provision of free fatty acid supplies metabolic substrate for ATP generation hence reducing the consumption of other substrates such as glutamine, which is the principal source of ammoniagenesis by the proximal tubule. This substrate competition, or metabolic switch, can lower the formation of the major urinary buffer ammonia, even in the absence of injury to the proximal tubule. With sustained lipid loading of the proximal tubule that exceeds its oxidative capacity, lipid storage is first activated but with time, toxic lipid metabolites may build up. We have evidence that excess saturated fat, which is prevalent in the Western diet, leads to proximal tubule lipotoxicity manifested as endoplasmic reticulum (ER) leakage/stress, and we propose that defective ammoniagenesis is part of a broader lipotoxic phenotype. We further propose that accumulation of a specific lipid species may be responsible for the toxicity. To test whether proximal tubule steatosis and lipotoxicity in humans have a functional consequence, we will study uric acid stone formers. Having previously shown that thiazolidinediones (TZD) reduce renal steatosis and lipotoxicity and improve ammonium excretion in animals, we have initiated a randomized intervention trial with TZD or placebo in human uric acid stone formers. The interim analysis showed that after 6 months of TZD therapy, stone formers had improved urinary biochemical parameters and reduced propensity for uric acid precipitation. We will continue this trial but add a novel highly sensitive method to non-invasively measure renal fat, testing whether improvement in urinary biochemistry associates with reduction of renal fat. This proposal addresses fundamental concepts of renal tubular lipid biology and lipotoxicity, and clinically will shift the paradigm of uric acid stone therapy from empiric urinary alkalinization to specific reduction in renal fat. We will also introduce cutting-edge human imaging studies for kidney research.

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 (Participant, Investigator)

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects with uric acid kidney stone disease
  • Age > 21 years

排除标准

  • Body weight> 350 lb
  • Chronic alcohol use
  • Chronic liver disease
  • Chronic renal disease
  • Contraindication to pioglitazone use:
  • history of congestive heart failure NYHA class III or IV
  • significant pedal edema
  • liver failure
  • not willing to practice an effective contraception for the duration of the study
  • Thiazolidinedione use in the preceding 18 months

研究组 & 干预措施

Pioglitazone

Experimental

For 60 Aim 2 Subjects Only - Pioglitazone (Actos)

干预措施: Pioglitazone (Drug)

Placebo

Placebo Comparator

For 60 Subjects in Aim 2 Only - Placebo for Pioglitazone

干预措施: Placebo (Drug)

结局指标

主要结局

Reversal of renal lipotoxicity will occur with pioglitazone.

时间窗: 6 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khashayar Sakhaee

Professor of Internal Medicine

University of Texas Southwestern Medical Center

研究点 (1)

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