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The central aim of this study is to improve understanding of how metabolic pathways that contribute to adiposity also amplify risks of kidney disease progression and cardiovascular disease in subjects with moderate to severe CKD. In order to achieve this goal, we propose the following aims through a randomized 2x2 factorial design trial in subjects with moderate to severe CKD: (a) To assess the feasibility of implementing aerobic exercise and caloric restriction interventions, and (b) To examine the effects of aerobic exercise and caloric restriction on a metabolic risk profile, including systemic measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction. Hypothesis: We hypothesize that implementation of caloric restriction and aerobic exercise is feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to severe CKD. Interim analysis may be performed (no specific plan at this time).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Springfield College
Springfield, Massachusetts, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Kidney Research Institute
Seattle, Washington, United States
Providence Sacred Heart Medical Research Center
Spokane, Washington, United States
Start Date
October 1, 2010
Primary Completion Date
February 1, 2014
Completion Date
February 1, 2014
Last Updated
July 25, 2014
122
ACTUAL participants
caloric restriction
OTHER
aerobic exercise
OTHER
Lead Sponsor
Vanderbilt University
Collaborators
NCT07241390
NCT06926660
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06717698