Chronic Kidney Disease Clinical Trial
Official title:
Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
The oxidative stress and inflammatory state is known to contribute to the pathogenesis of
atherosclerosis, and is predictive of cardiovascular events and mortality rates in the
general population and patients with chronic kidney disease (CKD), particularly in patients
with end stage renal disease (ESRD) on dialysis therapy 1. Increased oxidative stress and
inflammation has been identified in all stages of CKD, ranging from moderate renal
insufficiency to ESRD. However, the pathophysiology of increased oxidative stress and
inflammation associated with the development of CKD is currently poorly understood.
There is also concern about the epidemic of obesity in the United States, as the overall
health status of the general population is adversely affected by increasing adiposity.
Recent studies indicate a strong relationship between adiposity and incident CKD.
Furthermore, the presence of an elevated body mass index (BMI) is an independent predictor
for progression to ESRD, even after additional adjustments for baseline blood pressure and
the presence or absence of diabetes mellitus. Limited data in the general population show
that healthy lifestyle interventions, such as exercise and dietary caloric restriction,
either alone or in combination, reduce the inflammatory and oxidative stress burden seen in
obese subjects. The impact of healthy lifestyle modifications on inflammation and oxidative
stress has not been investigated in the obese CKD population. Based on the foregoing
observations, the purpose of this investigation will be to determine whether healthy
lifestyle interventions in the form of low-impact aerobic exercise and dietary calorie
restriction in obese subjects (BMI ≥ 30kg/m2) with moderate to severe (Stage III-IV) CKD
[estimated glomerular filtration rate (GFR) 20-59 ml/min] will improve oxidative stress,
inflammation, insulin resistance, adipocytokines, endothelial dysfunction, and quality of
life.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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