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TerminatedNCT00581269Updated Nov 3, 2010

Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease

A Phase 2 interventional study of low-impact aerobic exercise and low-calorie (low-fat) diet in Chronic Kidney Disease, sponsored by Vanderbilt University. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-11-03.

Sponsored by Vanderbilt University · Phase 2, Interventional, and Treatment

Why this study was terminated
the Fellow conducting the study left the institution in 2009
Phase
Phase 2
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Chronic Kidney Disease
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 3 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  1. Active inflammatory disease such as: AIDS (HIV seropositivity is not an exclusion criteria), active hepatitis C or B, active gout, other active inflammatory diseases.
  2. Active malignancy excluding basal or squamous cell carcinoma of the skin.
  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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Active comparator
    1

    low-impact aerobic exercise group

    Behavioral: low-impact aerobic exercise

  • Active comparator
    2

    dietary restriction group

    Dietary Supplement: low-calorie (low-fat) diet

  • No intervention
    3

    control group

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

06

What researchers measure

Primary outcomes

  1. a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker

    Time frame: 3 months

  2. a statistically significant decrease in hs-CRP, a specific inflammatory marker

    Time frame: 3 months

Secondary outcomes

  1. significant changes in additional markers of oxidative stress and inflammation

    Time frame: 3 months

  2. significant changes in insulin resistance and adipocytokines

    Time frame: 3 months

  3. a significant improvement in endothelial function as measured by brachial artery FMD

    Time frame: 3 months

  4. a significant improvement in quality of life scores

    Time frame: 3 months

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00581269
Lead sponsor
Vanderbilt University
First posted
Dec 27, 2007
Start date
Dec 2007
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Nov 3, 2010

Study contacts

Alp Ikizler, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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