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NCT03478722 · ClinicalTrials.gov registry record

Muscle Protein Synthesis in Dialysis Patients

A clinical trial, sponsored by University of Illinois at Urbana-Champaign.

Completed
Registry status
16
Enrollment target

NCT03478722: Completed study, sponsored by University of Illinois at Urbana-Champaign.

NCT03478722 is a clinical trial that has completed, run by University of Illinois at Urbana-Champaign. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03478722 has completed, sponsored by University of Illinois at Urbana-Champaign.

COMPLETED
Registry status
16 participants
Enrollment target

Study Summary

The most severe form of chronic renal failure is end-stage-renal-disease with maintenance hemodialysis (MHD) as the most common treatment strategy. MHD patients experience a number of metabolic and phenotypic derangements including skeletal muscle wasting. Previously, it has been demonstrated that dialysis treatment leads to increased rates of forearm phenylalanine uptake (proxy for 'muscle' protein synthesis) with an even greater rates of phenylalanine release (proxy for 'muscle' protein breakdown). Hence, the dialysis procedure itself is catabolic and induces a catabolic carryover for several hours after dialysis. This suggests prolonged post-dialysis disturbances in whole body- and skeletal muscle protein metabolism in MHD patients. Moreover, dialysis treatment in itself results in \~20 % losses of circulating amino acids in the dialysate. Collectively, this creates the need for replacement of amino acids by protein supplementation during and/or after dialysis. The ingestion of protein-dense meals in between dialysis treatments likely represents an important dietary strategy to counterbalance dialysis-induced catabolism and to achieve the current recommended protein intakes (set at 1.2 g/kg bodyweight/d) to limit muscle protein loss in MHD patients. However, the effectiveness of protein-rich meal ingestion to augment postprandial whole body and muscle protein metabolic responses in MHD patients outside of the dialysis period remain largely undefined. The purpose of this study is to compare basal and postprandial whole body leucine body kinetics, muscle anabolic sensing mechanisms, markers of muscle proteolysis, and myofibillar protein synthesis rates to mixed meal ingestion on a non-dialysis day in eight MHD patients, between 20-80 and to compare these outcomes to age- and BMI-matched controls. The investigators will use specifically produced intrinsically L-\[5,5,5-2H3\]leucine labeled eggs combined with primed constant amino acid tracer infusion methods and co

Primary Outcome

Measurement of muscle protein synthesis

Interventions

  • OTHER Protein Meal
  • OTHER Stable Isotope Amino Acid Infusion

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2017-01-18
Est. Completion 2018-04-01

What the finished NCT03478722 record still lists

NCT03478722 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.

The record links to 0 conditions, and to 2 interventions - of which Protein Meal is the first listed.

NCT03478722 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03478722 about?

NCT03478722 is a clinical study titled "Muscle Protein Synthesis in Dialysis Patients". The most severe form of chronic renal failure is end-stage-renal-disease with maintenance hemodialysis (MHD) as the most common treatment strategy. MHD patients experience a number of metabolic and phenotypic derangements including skeletal muscle wasting. Previously, it has been demonstrated that d...

What is the current status of trial NCT03478722?

This trial is currently completed. The enrollment target is 16 participants. The study started on 2017-01-18. Estimated completion is 2018-04-01.

What interventions are being tested in trial NCT03478722?

The interventions under investigation include: Protein Meal (OTHER), Stable Isotope Amino Acid Infusion (OTHER).

Who is sponsoring clinical trial NCT03478722?

This trial is sponsored by University of Illinois at Urbana-Champaign, which has 129 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03478722, the US trial registry maintained by the National Library of Medicine. NCT03478722 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.