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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

Tracking Information
First Submitted Date  ICMJE June 23, 2010
First Posted Date  ICMJE June 28, 2010
Last Update Posted Date July 25, 2014
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2010)
a change in plasma F-2-isoprostane concentration [ Time Frame: baseline and 4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Official Title  ICMJE Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Other: caloric restriction
  • Active Comparator: aerobic exercise
    supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration
    Intervention: Other: aerobic exercise
  • 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
    Interventions:
    • Other: caloric restriction
    • Other: aerobic exercise
  • No Intervention: usual diet and usual activity
    usual diet and usual activity
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 22, 2014)
122
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2010)
144
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01150851
Other Study ID Numbers  ICMJE 100716
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alp Ikizler, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE University of Washington
Investigators  ICMJE
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Principal Investigator: Jonathan Himmelfarb, MD University of Washington
PRS Account Vanderbilt University
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP