Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: caloric restriction; Other: aerobic exercise

• Registration Number: NCT01150851
• Lead Sponsor: Vanderbilt University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Study Start: 2010-10
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-24
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• Stage III-IV CKD measured by the MDRD equation with eGFR 15-60 ml/min/1.73m2;
• Age 18-75 years;
• BMI ≥ 25;
• Life expectancy ≥ 1 year;
• Ability to understand and provide informed consent.

Exclusion Criteria

• Any acute inflammatory condition (including chronic infection requiring treatment, and collagen vascular disease including active gout);
• Pregnancy;
• Taking high-dose anti-oxidants (Vitamin E or C);
• Chronic use of anti-inflammatory medication except low dose (< 10mg/d) prednisone and aspirin (< 100 mg/day);
• Significant cardiac or vascular disease (symptomatic disease or CV event including congestive heart failure within 6 months);
• Significant occlusive atherosclerotic disease or ischemic disease (on non-invasive or invasive diagnostic procedures);
• Significant physical immobility or disabilities (joint replacement, muscular disorders);
• Type I diabetes mellitus, or Type II requiring insulin therapy;
• History of poor adherence to medical regimen;
• Those subjects who have a diagnosis of atrial fibrillation or a pacemaker will be allowed in the study but will not undergo Arterial Tonometry (PWV) studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
a change in VO2 max	baseline and 4 months
a change in weight	baseline and 4 months
a change in absolute fat mass	baseline and 4 months
a change in plasma F-2-isoprostane concentration	baseline and 4 months

Secondary Outcome Measures

Name	Time	Method
a change in biomarkers of endothelial dysfunction	baseline and 4 months
a change in biomarkers of insulin resistance	baseline and 4 months
a change in biomarkers of inflammation	baseline and 4 months

Trial Locations

Locations (4)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Springfield College; 🇺🇸 Springfield, Massachusetts, United States

Kidney Research Institute; 🇺🇸 Seattle, Washington, United States

Providence Sacred Heart Medical Research Center; 🇺🇸 Spokane, Washington, United States