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NCT00581269 · ClinicalTrials.gov registry record · Phase 2
Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
A Phase 2 study, sponsored by Vanderbilt University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT00581269 is a Phase 2 study that was terminated before completion, run by Vanderbilt University. The registered enrollment target is 3 participants.
The verdict
NCT00581269, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study 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
- BEHAVIORAL low-impact aerobic exercise
- DIETARY_SUPPLEMENT low-calorie (low-fat) diet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00581269
The ClinicalTrials.gov registry entry for NCT00581269 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which low-impact aerobic exercise is the first listed.
NCT00581269 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00581269 about?
NCT00581269 is a clinical study titled "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 (E...
What is the current status of trial NCT00581269?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2007-12. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00581269?
The interventions under investigation include: low-impact aerobic exercise (BEHAVIORAL), low-calorie (low-fat) diet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00581269?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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