Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Sponsor

Vanderbilt University (Other)

Overall Status

Completed

CT.gov ID

NCT01150851

Collaborator

University of Washington (Other)

122

Enrollment

Locations

Arms

Duration (Months)

30.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2010

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

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

Primary Outcome Measures

a change in plasma F-2-isoprostane concentration [baseline and 4 months]
a change in VO2 max [baseline and 4 months]
a change in weight [baseline and 4 months]
a change in absolute fat mass [baseline and 4 months]

Secondary Outcome Measures

a change in biomarkers of inflammation [baseline and 4 months]
a change in biomarkers of endothelial dysfunction [baseline and 4 months]
a change in biomarkers of insulin resistance [baseline and 4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Springfield College	Springfield	Massachusetts	United States	01109-3797
2	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
3	Kidney Research Institute	Seattle	Washington	United States	98104
4	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alp Ikizler, Professor, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01150851

Other Study ID Numbers:

100716

First Posted:

Jun 28, 2010

Last Update Posted:

Jul 25, 2014

Last Verified:

Jul 1, 2014

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 25, 2014