跳至主要内容
临床试验/NCT07422792
NCT07422792招募中不适用

Anabolic Response To Protein And Assessment Of Metabolic Phenotype In Patients With Home Parenteral Nutrition And Chronic Intestinal Failure

Institute of Oncology Ljubljana1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Whole-Body Protein Kinetics (Protein Synthesis Rate) After Intravenous Amino Acid Infusion

研究概览

简要总结

The purpose of this study is to gain insight into the actual protein requirements of patients with chronic intestinal failure (CIF) receiving home parenteral nutrition, which could improve clinical management of these patients. Based on collected data on protein kinetics, the study aims to further refine and personalize nutritional mixtures in patients with CIF. Additional aims include assessment of short-chain fatty acid metabolism and evaluation of gut microbiota function in patients with CIF.

详细描述

This prospective cohort study evaluates anabolic response to intravenous amino acid administration and metabolic phenotype in patients with chronic intestinal failure (CIF) receiving home parenteral nutrition. The study aims to improve therapy of CIF patients by providing new insights into metabolism and anabolic response. Protein kinetics will be assessed to better define protein requirements and to support optimization and personalization of parenteral nutrition mixtures. The study will also assess short-chain fatty acid metabolism and provide insight into gut microbiota function in CIF patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • - Patients with chronic intestinal failure (CIF) receiving home parenteral nutrition.

排除标准

  • 未提供

研究组 & 干预措施

Intravenous Amino Acid Administration

Experimental

Patients with chronic intestinal failure receiving home parenteral nutrition receive intravenous amino acid administration for assessment of anabolic response and metabolic phenotype.

干预措施: Intravenous Amino Acids (Drug)

结局指标

主要结局

Whole-Body Protein Kinetics (Protein Synthesis Rate) After Intravenous Amino Acid Infusion

时间窗: Baseline (prior to amino acid infusion) and immediately after amino acid infusion (within 1 day)

Protein anabolic response will be assessed by whole-body protein kinetics using a stable isotope tracer methodology during intravenous amino acid administration. The outcome will be reported as the change in whole-body protein synthesis rate (µmol/kg/h) from baseline to post-infusion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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