Chronic Kidney Disease
Conditions
Brief summary
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.
Interventions
BEHAVIORALlow-impact aerobic exercise
subjects will undergo supervised physical activity for a maximum of 30-60 minutes, every other day, 3 days per week for 3 months; to offer variety in the exercise prescription, subjects will alternately use a treadmill, an elliptical trainer, a Nu-Step cross-trainer and a recumbent stationary bicycle
DIETARY_SUPPLEMENTlow-calorie (low-fat) diet
subjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with Stage III-IV (estimated GFR 20-59 min/ml) chronic kidney disease measured by MDRD formula. 2. BMI ≥ 30 kg/m2 3. Age \> 18 or \< 65 years. 4. Life expectancy greater than one year. 5. Ability to understand and provide informed consent for participation in the study.
Exclusion criteria
1. Active inflammatory disease such as: AIDS (HIV seropositivity is not an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker | 3 months |
| a statistically significant decrease in hs-CRP, a specific inflammatory marker | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| significant changes in additional markers of oxidative stress and inflammation | 3 months |
| significant changes in insulin resistance and adipocytokines | 3 months |
| a significant improvement in endothelial function as measured by brachial artery FMD | 3 months |
| a significant improvement in quality of life scores | 3 months |
Countries
United States
Outcome results
None listed