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Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
caloric restriction
aerobic exercise
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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.

Sites / Locations

  • Springfield College
  • Vanderbilt University Medical Center
  • Kidney Research Institute
  • Providence Sacred Heart Medical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

caloric restriction

aerobic exercise

caloric restriction and aerobic exercise

usual diet and usual activity

Arm Description

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

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

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

usual diet and usual activity

Outcomes

Primary Outcome Measures

a change in plasma F-2-isoprostane concentration
a change in VO2 max
a change in weight
a change in absolute fat mass

Secondary Outcome Measures

a change in biomarkers of inflammation
a change in biomarkers of endothelial dysfunction
a change in biomarkers of insulin resistance

Full Information

First Posted
June 23, 2010
Last Updated
July 24, 2014
Sponsor
Vanderbilt University
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01150851
Brief Title
Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Official Title
Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
University of Washington

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
caloric restriction
Arm Type
Active Comparator
Arm Description
10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration
Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Description
supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration
Arm Title
caloric restriction and aerobic exercise
Arm Type
Active Comparator
Arm Description
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
Arm Title
usual diet and usual activity
Arm Type
No Intervention
Arm Description
usual diet and usual activity
Intervention Type
Other
Intervention Name(s)
caloric restriction
Intervention Description
10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration
Primary Outcome Measure Information:
Title
a change in plasma F-2-isoprostane concentration
Time Frame
baseline and 4 months
Title
a change in VO2 max
Time Frame
baseline and 4 months
Title
a change in weight
Time Frame
baseline and 4 months
Title
a change in absolute fat mass
Time Frame
baseline and 4 months
Secondary Outcome Measure Information:
Title
a change in biomarkers of inflammation
Time Frame
baseline and 4 months
Title
a change in biomarkers of endothelial dysfunction
Time Frame
baseline and 4 months
Title
a change in biomarkers of insulin resistance
Time Frame
baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Himmelfarb, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Springfield College
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01109-3797
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Kidney Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Providence Sacred Heart Medical Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34843657
Citation
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.
Results Reference
derived
PubMed Identifier
33782940
Citation
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.
Results Reference
derived
PubMed Identifier
32571614
Citation
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.
Results Reference
derived

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Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

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