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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581269
Recruitment Status : Terminated (the Fellow conducting the study left the institution in 2009)
First Posted : December 27, 2007
Last Update Posted : November 3, 2010
Information provided by:
Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Behavioral: low-impact aerobic exercise Dietary Supplement: low-calorie (low-fat) diet Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dietary Intervention and Exercise Training (DIET) in Moderate to Severe Chronic Kidney Disease
Study Start Date : December 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
low-impact aerobic exercise group
Behavioral: 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

Active Comparator: 2
dietary restriction group
Dietary Supplement: 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

No Intervention: 3
control group

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581269

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: Alp Ikizler, MD Vanderbilt University Medical Center

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center Identifier: NCT00581269     History of Changes
Other Study ID Numbers: 070990
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: November 3, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency