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CompletedNCT01150851Updated Jul 25, 2014

Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

An interventional study of caloric restriction and aerobic exercise in Chronic Kidney Disease, sponsored by Vanderbilt University. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-07-25.

Sponsored by Vanderbilt University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The central aim of this study is to improve understanding of how metabolic pathways that contribute to adiposity also amplify risks of kidney disease progression and cardiovascular disease in subjects with moderate to severe CKD. In order to achieve this goal, we propose the following aims through a randomized 2x2 factorial design trial in subjects with moderate to severe CKD: (a) To assess the feasibility of implementing aerobic exercise and caloric restriction interventions, and (b) To examine the effects of aerobic exercise and caloric restriction on a metabolic risk profile, including systemic measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction.

Hypothesis: We hypothesize that implementation of caloric restriction and aerobic exercise is feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress, inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to severe CKD.

Interim analysis may be performed (no specific plan at this time).

02

Conditions studied

  • Chronic Kidney Disease
03

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 122 is above 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 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Stage III-IV CKD measured by the MDRD equation with eGFR 15-60 ml/min/1.73m2;
  • Age 18-75 years;
  • BMI ≥ 25;
  • Life expectancy ≥ 1 year;
  • Ability to understand and provide informed consent.

Exclusion criteria

Exclusion Criteria:

  • Any acute inflammatory condition (including chronic infection requiring treatment, and collagen vascular disease including active gout);
  • Pregnancy;
  • Taking high-dose anti-oxidants (Vitamin E or C);
  • Chronic use of anti-inflammatory medication except low dose (\< 10mg/d) prednisone and aspirin (\< 100 mg/day);
  • Significant cardiac or vascular disease (symptomatic disease or CV event including congestive heart failure within 6 months);
  • Significant occlusive atherosclerotic disease or ischemic disease (on non-invasive or invasive diagnostic procedures);
  • Significant physical immobility or disabilities (joint replacement, muscular disorders);
  • Type I diabetes mellitus, or Type II requiring insulin therapy;
  • History of poor adherence to medical regimen;
  • Those subjects who have a diagnosis of atrial fibrillation or a pacemaker will be allowed in the study but will not undergo Arterial Tonometry (PWV) studies.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
122 participants (actual)

Study arms

  • Active comparator
    caloric restriction

    10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration

    Other: caloric restriction

  • Active comparator
    aerobic exercise

    supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

    Other: aerobic exercise

  • Active comparator
    caloric restriction and aerobic exercise

    10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration, and supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

    Other: caloric restriction · Other: aerobic exercise

  • No intervention
    usual diet and usual activity

    usual diet and usual activity

Interventions

  • Othercaloric restriction

    10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration

  • Otheraerobic exercise

    supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration

06

What researchers measure

Primary outcomes

  1. a change in plasma F-2-isoprostane concentration

    Time frame: baseline and 4 months

  2. a change in VO2 max

    Time frame: baseline and 4 months

  3. a change in weight

    Time frame: baseline and 4 months

  4. a change in absolute fat mass

    Time frame: baseline and 4 months

Secondary outcomes

  1. a change in biomarkers of inflammation

    Time frame: baseline and 4 months

  2. a change in biomarkers of endothelial dysfunction

    Time frame: baseline and 4 months

  3. a change in biomarkers of insulin resistance

    Time frame: baseline and 4 months

07

Study locations

4 sites
  • Springfield College
    Springfield, Massachusetts 01109-3797, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Kidney Research Institute
    Seattle, Washington 98104, United States
  • Providence Sacred Heart Medical Research Center
    Spokane, Washington 99204, United States
08

References and documents

Publications

  • Jaramillo-Morales J, Korucu B, Pike MM, Lipworth L, Stewart T, Headley SAE, Germain M, Begue G, Roshanravan B, Tuttle KR, Himmelfarb J, Robinson-Cohen C, Ikizler TA, Gamboa JL. Effects of caloric restriction and aerobic exercise on circulating cell-free mitochondrial DNA in patients with moderate to severe chronic kidney disease. Am J Physiol Renal Physiol. 2022 Jan 1;322(1):F68-F75. doi: 10.1152/ajprenal.00270.2021. Epub 2021 Nov 29. PubMed 34843657 ↗
  • Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2. PubMed 33782940 ↗
  • Aydemir N, Pike MM, Alsouqi A, Headley SAE, Tuttle K, Evans EE, Milch CM, Moody KA, Germain M, Lipworth L, Himmelfarb J, Ikizler TA, Robinson-Cohen C. Effects of diet and exercise on adipocytokine levels in patients with moderate to severe chronic kidney disease. Nutr Metab Cardiovasc Dis. 2020 Jul 24;30(8):1375-1381. doi: 10.1016/j.numecd.2020.04.012. Epub 2020 Apr 21. PubMed 32571614 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01150851
Lead sponsor
Vanderbilt University
Collaborators
University of Washington
Responsible party
Alp Ikizler (Professor, Vanderbilt University) — Principal investigator
First posted
Jun 28, 2010
Start date
Oct 2010
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Jul 25, 2014

Study contacts

Alp Ikizler, MD
principal investigator · Vanderbilt University
Jonathan Himmelfarb, MD
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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