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Trial record 1 of 1 for:    NCT01150851
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Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

This study has been completed.
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Alp Ikizler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01150851
First received: June 23, 2010
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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 Intervention
Chronic Kidney Disease
Other: caloric restriction
Other: aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 122
Study Start Date: October 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150851

Locations
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
Principal Investigator: Alp Ikizler, MD Vanderbilt University
Principal Investigator: Jonathan Himmelfarb, MD University of Washington
  More Information

Responsible Party: Alp Ikizler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01150851     History of Changes
Other Study ID Numbers: 100716
Study First Received: June 23, 2010
Last Updated: July 24, 2014

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

ClinicalTrials.gov processed this record on March 22, 2017