Clinical trial NCT01150851: Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Official title: Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2010-06-28
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: a change in plasma F-2-isoprostane concentration
timeFrame: baseline and 4 months
measure: a change in VO2 max
timeFrame: baseline and 4 months
measure: a change in weight
timeFrame: baseline and 4 months
measure: a change in absolute fat mass
timeFrame: baseline and 4 months
Secondary outcomes:
measure: a change in biomarkers of inflammation
timeFrame: baseline and 4 months
measure: a change in biomarkers of endothelial dysfunction
timeFrame: baseline and 4 months
measure: a change in biomarkers of insulin resistance
timeFrame: baseline and 4 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Springfield College
state: Massachusetts
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Kidney Research Institute
state: Washington
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Research Center
state: Washington
Study officials:
affiliation: Vanderbilt University
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Jonathan Himmelfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.