Expired Study
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Nashville, Tennessee 37232


Purpose:

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.


Criteria:

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).


Study is Available At:


Original ID:

070990


NCT ID:

NCT00581269


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

the Fellow conducting the study left the ins


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

3


Enrollment Type:

Actual


Overall Contact Information

Official Name:Alp Ikizler, MD
Principal Investigator
Vanderbilt University

Study Dates

Start Date:December 2007
Completion Date:April 2009
Completion Type:Actual
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 1, 2010
First Received Date:December 18, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:a statistically significant decrease in plasma F2-isoprostanes, a specific oxidative stress marker
Time Frame:3 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:a statistically significant decrease in hs-CRP, a specific inflammatory marker
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:significant changes in additional markers of oxidative stress and inflammation
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:significant changes in insulin resistance and adipocytokines
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:a significant improvement in endothelial function as measured by brachial artery FMD
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:a significant improvement in quality of life scores
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:low-impact aerobic exercise
Description: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
Arm Name:1
Intervention Type:Dietary Supplement
Name:low-calorie (low-fat) diet
Description:subjects will undergo a 20% reduction in total daily calories from their usual daily energy consumption every day for 3 months
Arm Name:2

Study Arms

Study Arm Type:No Intervention
Arm Name:3
Description:control group
Study Arm Type:Active Comparator
Arm Name:2
Description:dietary restriction group
Study Arm Type:Active Comparator
Arm Name:1
Description:low-impact aerobic exercise group

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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