Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
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ClinicalTrials.gov Identifier: NCT01150851 |
Recruitment Status :
Completed
First Posted : June 28, 2010
Last Update Posted : July 25, 2014
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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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease | Other: caloric restriction Other: aerobic exercise | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Oxidative Stress in Chronic Kidney Disease: Diet and Exercise |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 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
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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 |
Active Comparator: aerobic exercise
supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration
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Other: aerobic exercise
supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration |
Active Comparator: 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
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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 |
No Intervention: usual diet and usual activity
usual diet and usual activity
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- a change in plasma F-2-isoprostane concentration [ Time Frame: baseline and 4 months ]
- a change in VO2 max [ Time Frame: baseline and 4 months ]
- a change in weight [ Time Frame: baseline and 4 months ]
- a change in absolute fat mass [ Time Frame: baseline and 4 months ]
- a change in biomarkers of inflammation [ Time Frame: baseline and 4 months ]
- a change in biomarkers of endothelial dysfunction [ Time Frame: baseline and 4 months ]
- a change in biomarkers of insulin resistance [ Time Frame: baseline and 4 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150851
United States, Massachusetts | |
Springfield College | |
Springfield, Massachusetts, United States, 01109-3797 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Kidney Research Institute | |
Seattle, Washington, United States, 98104 | |
Providence Sacred Heart Medical Research Center | |
Spokane, Washington, United States, 99204 |
Principal Investigator: | Alp Ikizler, MD | Vanderbilt University | |
Principal Investigator: | Jonathan Himmelfarb, MD | University of Washington |
Responsible Party: | Alp Ikizler, Professor, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT01150851 |
Other Study ID Numbers: |
100716 |
First Posted: | June 28, 2010 Key Record Dates |
Last Update Posted: | July 25, 2014 |
Last Verified: | July 2014 |
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |