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临床试验/NCT01810614
NCT01810614已完成不适用

A New Diet for Patients With Autosomal Dominant Polycystic Disease (ADPKD)

University of Kansas2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年2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
12
试验地点
2
主要终点
ADPKD diet impact on net acid excretion

研究概览

简要总结

Recent evidence has shown that kidney volume predicts the likelihood of developing renal insufficiency over a finite length of time in ADPKD, suggesting a linkage between the growth of cysts and the harm they do to kidney function. Recent studies indicate that the rate of kidney volume increase is hastened by excess dietary protein, salt, and potential net acid precursors, and slowed by increased water intake sufficient to lower plasma vasopressin levels.

Diets are commonly prescribed to treat ADPKD and other renal patients with disease near the end-stage, but there is currently no specific diet prescription that takes potentially harmful dietary elements into account for ADPKD patients in the earliest stages of the disease. This study will examine a novel diet for ADPKD created by the researcher termed the ADPKD diet.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have not been prescribed dietary restrictions or enhancements
  • Blood pressure <135/85 mmHg with or without specific treatment
  • Willingness to participate for at least one month
  • Diet history consistent with the excretion of >30 mEq NAE / day based on usual dietary intake

排除标准

  • Other active diseases requiring pharmacologic agents
  • Unstable weight (+/- 2 kg) for 3 months prior to enrollment
  • Food allergies
  • Pregnancy or lactating
  • Confounding medications, i.e. bicarbonate, citrate
  • Individuals who do not consume meat for personal, religious, or health reasons.

结局指标

主要结局

ADPKD diet impact on net acid excretion

时间窗: Change from Baseline to Day 36

The difference in net acid excretion from a participants regular diet and the ADPKD diet

次要结局

  • Acceptance of ADPKD diet(36 days)
  • Kidney injury markers(Change from Baseline to Day 36)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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