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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
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University

Study Description
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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).


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: caloric restriction Other: aerobic exercise Not Applicable

Study Design
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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

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Arms and Interventions
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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
 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
 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
 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


Outcome Measures
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Primary Outcome Measures :
  1. a change in plasma F-2-isoprostane concentration [ Time Frame: baseline and 4 months ]
  2. a change in VO2 max [ Time Frame: baseline and 4 months ]
  3. a change in weight [ Time Frame: baseline and 4 months ]
  4. a change in absolute fat mass [ Time Frame: baseline and 4 months ]

Secondary Outcome Measures :
  1. a change in biomarkers of inflammation [ Time Frame: baseline and 4 months ]
  2. a change in biomarkers of endothelial dysfunction [ Time Frame: baseline and 4 months ]
  3. a change in biomarkers of insulin resistance [ Time Frame: baseline and 4 months ]

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Vanderbilt University
University of Washington
Investigators
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Principal Investigator: Alp Ikizler, MD Vanderbilt University
Principal Investigator: Jonathan Himmelfarb, MD University of Washington
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency