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Completed

NCT Number: NCT01150851

Oxidative Stress in Chronic Kidney Disease: Diet and Exercise

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Springfield College, Springfield, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Aerobic Exercise

Other

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

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

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • University of Washington

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2010
Registry last updated
Jul 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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