Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

caloric restriction

Intervention Type OTHER

10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration

aerobic exercise

supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

Group Type ACTIVE_COMPARATOR

aerobic exercise

Intervention Type OTHER

supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

caloric restriction and 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

Group Type ACTIVE_COMPARATOR

caloric restriction

Intervention Type OTHER

10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration

aerobic exercise

Intervention Type OTHER

supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

usual diet and usual activity

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

aerobic exercise

supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No