NCT01150851

Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
OTHER	caloric restriction	10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration
OTHER	aerobic exercise	supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2010-06-28
• Last updated: 2014-07-25

Locations

4 sites across 1 country: United States