Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Status:	Completed
Conditions:	Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:	Nephrology / Urology
Healthy:	No
Age Range:	18 - 75
Updated:	3/1/2014
Start Date:	October 2010
End Date:	December 2014
Contact:	Alp Ikizler, MD
Email:	alp.ikizler@vanderbilt.edu
Phone:	615-343-6104

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).

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.

We found this trial at

sites

Vanderbilt University Medical Center

1211 Medical Center Dr
Nashville, Tennessee 37232

(615) 322-5000