MedTrace Logo

Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease

NCT04067752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-11-08

No results posted yet for this study

Summary

By 2030 an estimated 2 million people in the US will need dialysis or transplantation. Insulin resistance and chronic inflammation are common in dialysis patients and have been linked to protein-energy wasting, the most important determinant of clinical outcome in this patient population. The investigators hypothesize that the skin and muscle tissue sodium accumulation is a critical mechanism by which chronic inflammatory response and insulin resistance, alone or in combination lead to protein energy wasting in hemodialysis patients. The investigators will test this hypothesis by studying dialysis patients and matched controls without kidney disease by examining tissue Na content, markers of inflammation and protein metabolism.

Conditions

  • End-stage Renal Disease

Interventions

OTHER

high dialysate sodium concentration (138 mEq/L)

high dialysate sodium concentration (138 mEq/L)

OTHER

Low dialysate sodium concentration

low dialysate sodium concentration (132 mEq/L)

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Talat A Ikizler, MD · Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-05-15
Completion
2024-05-20

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04067752 on ClinicalTrials.gov