Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
NCT ID: NCT00581269
Last Updated: 2010-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2007-12-31
2009-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
low-impact aerobic exercise group
low-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
2
dietary restriction group
low-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
3
control group
No interventions assigned to this group
Interventions
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low-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
low-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
Eligibility Criteria
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Inclusion Criteria
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
3. Patients suffering from Type I Diabetes Mellitus
4. Patients with reduced daily caloric intake at baseline (≤ 2000 kcal/day) or malnutrition.
5. Patients who are already on a consistent and rigorous exercise regimen.
6. Gastrointestinal dysfunction requiring parental nutrition.
7. History of functional kidney transplant \< 6 months prior to study entry.
8. Anticipated live donor kidney transplant over study duration.
9. Patients taking anti-inflammatory medication except aspirin \< 325mg/day over the past 30 days.
10. Patients taking Vitamin E supplements \> 60 IU/day, vitamin C \> 500mg/day over the past 30days.
11. Patients taking any prednisone therapy.
12. Hospital admission within the last 30 days.
13. On experimental drug protocols.
14. Significant cardiac or vascular disease (symptomatic disease; CV event(s) within the last year; significant occlusive atherosclerotic disease or ischemic disease on non-invasive or invasive diagnostic procedures).
15. Significant physical disability or immobility (joint disease, joint replacement, muscular disorders).
18 Years
65 Years
ALL
No
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Vanderbilt University Medical Center
Principal Investigators
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Alp Ikizler, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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070990
Identifier Type: -
Identifier Source: org_study_id