Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Chronic Kidney Disease Clinical Trial

Official title:

Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150851
• Other study ID #: 100716
• Status: Completed
• Phase: N/A
• First received: June 23, 2010
• Last updated: July 24, 2014
• Start date: October 2010
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
• aerobic exercise
supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Kidney Research Institute	Seattle	Washington
United States	Providence Sacred Heart Medical Research Center	Spokane	Washington
United States	Springfield College	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a change in plasma F-2-isoprostane concentration		baseline and 4 months	No
Primary	a change in VO2 max		baseline and 4 months	No
Primary	a change in weight		baseline and 4 months	No
Primary	a change in absolute fat mass		baseline and 4 months	No
Secondary	a change in biomarkers of inflammation		baseline and 4 months	No
Secondary	a change in biomarkers of endothelial dysfunction		baseline and 4 months	No
Secondary	a change in biomarkers of insulin resistance		baseline and 4 months	No