Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

NCT01150851 | Completed DMC

• 1 other identifier: 100716
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 4

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).

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (4)

• a change in plasma F-2-isoprostane concentration

  baseline and 4 months

• a change in VO2 max

  baseline and 4 months

• a change in weight

  baseline and 4 months

• a change in absolute fat mass

  baseline and 4 months

Secondary Outcomes (3)

• a change in biomarkers of inflammation

  baseline and 4 months

• a change in biomarkers of endothelial dysfunction

  baseline and 4 months

• a change in biomarkers of insulin resistance

  baseline and 4 months

Study Arms (4)

caloric restriction

ACTIVE COMPARATOR

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

aerobic exercise

ACTIVE COMPARATOR

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

Other: aerobic exercise

caloric restriction and aerobic exercise

ACTIVE COMPARATOR

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

usual diet and usual activity

NO INTERVENTION

usual diet and usual activity

Interventions

caloric restriction OTHER

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

caloric restriction; caloric restriction and aerobic exercise

aerobic exercise OTHER

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

aerobic exercise; caloric restriction and aerobic exercise

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• University of Washington: collaborator

Study Sites (4)

Springfield College

Springfield, Massachusetts, 01109-3797, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Kidney Research Institute

Seattle, Washington, 98104, United States

Location

Providence Sacred Heart Medical Research Center

Spokane, Washington, 99204, United States

Location

Related Publications (3)

• 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.

  PMID: 34843657 DERIVED

• 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.

  PMID: 33782940 DERIVED

• 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.

  PMID: 32571614 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Caloric Restriction; Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alp Ikizler, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Jonathan Himmelfarb, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 28, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

US (4)