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临床试验/NCT01890811
NCT01890811撤回不适用

Chronic Kidney Disease in Relation to Alterations in Protein and Amino Acid Metabolism and Function

Texas A&M University2 个研究点 分布在 1 个国家开始时间: 2013年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Net whole-body protein synthesis

研究概览

简要总结

Weight loss commonly occurs in patients with chronic kidney disease (CKD), negatively influencing their quality of life, treatment response and survival. Loss of muscle protein is generally a central component of weight loss in CKD patients but patients also have reductions in fat mass and bone density, independent of the severity of the disease state. Attempts to reverse weight and muscle loss in CKD and improve nutritional status by nutritional supplementation have been unsuccessful and there are currently no approved therapies.

Purpose of this study is to provide detailed insight in disease related gut function by obtaining information on gut permeability, digestion and absorption of glucose, fat and protein in CKD patients compared to matched healthy controls. Additionally, to examine whether protein and amino acid metabolism is disturbed in CKD patients compared to healthy controls. This will provide required information that will lead to implement new strategies to develop optimal nutritional regimen in order to enhance nutritional status, quality of life and survival in relation to kidney disease.

详细描述

This study involves one test day of approximately 7-8 hours. On this test day subjects will ingest a sugar drink to assess gut permeability and gut function, and a protein meal to measure digestion/absorption and the anabolic response to food intake. Subjects will also receive a mixture of amino acids that are made a little heavier than normal, called stable isotopes. This stable isotopes is used to investigate protein behavior in the body (protein kinetics). Blood (100-120 ml in total) and urine samples will be collected over 7.5 hours.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Net whole-body protein synthesis

时间窗: 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 min post-meal

Change in whole-body protein synthesis rate after intake of meal

次要结局

  • Cognitive function(1 day)
  • Tryptophan turnover rate(Postabsorptive state during 3 hours)
  • Myofibrillar protein breakdown rate(0,15,30,45,60,75,90,105,120,150,180,210 min post-meal)
  • Glycine rate of appearance(Postabsorptive state during 3 hours)
  • Skeletal and respiratory muscle strength(1 day)
  • Glucose absorption(7 hours)
  • Gut permeability(7 hours)
  • Insulin response to feeding(During 3 hours after feeding)
  • Citrulline Rate of appearance(Postabsorptive state during 3 hours)
  • Fatty acid digestion after feeding(0,15,30,45,60,75,90,105,120,150,180,210 min post-meal)
  • Protein digestion after feeding(0,15,30,45,60,75,90,105,120,150,180,210, min post-meal)
  • Arginine turnover rate(Postabsorptive state during 3 hours)
  • Whole body collagen breakdown rate(Postabsorptive state during 3 hours)
  • Fat-free mass(Postabsorptive state during 15 min)
  • Taurine turnover rate(Postabsorptive state during 3 hours)

研究者

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

Marielle PKJ Engelen, PhD

PhD

Texas A&M University

研究点 (2)

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