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Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00566670
Recruitment Status : Completed
First Posted : December 3, 2007
Last Update Posted : August 11, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 grams per kilogram per day (g/kg/d) in hemodialysis patients. However, it is unclear whether consumption of high amounts of protein in dialysis patients has beneficial or harmful nutritional and cardiovascular effects in this population. High protein intake might improve nutritional status, but it has been argued that the state of low muscle mass, small body size and low serum protein levels is not the result of decreased dietary intake, rather a result of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress.

The specific aims of this study are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake or dietary protein intake with muscle mass and arterial stiffness.

Condition or disease
End Stage Renal Disease

Detailed Description:

It is hypothesized that in the dialysis population overall: (1) Protein intake is a major determinant of muscle mass while inflammation, oxidative stress and metabolic acidosis play a lesser role; (2) Malnutrition is not an uremic cardiovascular risk factor hence low protein intake does not cause cardiovascular disease; and (3) In the other extreme, high protein intake is also not a major cause of cardiovascular disease since high serum phosphorus associated with high protein intake can usually be controlled by the use of phosphorus binders in routine clinical practice.

The specific aims of this proposal are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake (TPI) in grams/day, or dietary protein intake (DPI) normalized to body weight in grams/kilogram/day) with

  1. Nutritional status (mid-thigh muscle mass as measured by Magnetic Resonance Imaging ) and functional status (6-min walk) and
  2. Arterial stiffness (aortic pulse wave velocity)

Understanding the relationship between protein intake with body composition (muscle mass) and intermediate cardiovascular outcomes (arterial stiffness) in stage 5 CKD patients in hemodialysis is of great scientific and practical significance

Study Design

Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protein Intake, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease (CKD)
Study Start Date : September 2007
Primary Completion Date : October 2015
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Groups and Cohorts

Observation (all participants)
Stage 5 Chronic Kidney Disease and hemodialysis patients

Outcome Measures

Primary Outcome Measures :
  1. Correlation of muscle mass with protein intake [ Time Frame: Baseline and 18 months ]
    Mid-thigh muscle mass measured by magnetic resonance imaging

Secondary Outcome Measures :
  1. Correlation of arterial stiffness with protein intake [ Time Frame: Baseline and 18 months ]
    Radial artery stiffness measured by pulse wave velocity and pulse wave assessment

Biospecimen Retention:   Samples With DNA

30 ml of blood drawn four times (months 1, 6, 12 and 18) for plasma/serum/DNA samples.

Urine Collection: If patients are making more than ½ cup (200 ml) of urine a day.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
University of Utah Dialysis Program patients, and Vanderbilt University dialysis patients.

Inclusion Criteria:

  • Adult stage 5 chronic kidney disease patients, on dialysis for at least 3 months.
  • Urine output > 200 mL/day

Exclusion Criteria:

  • Patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight
  • Patients with inability to walk or who use a wheel-chair with reduced mid-thigh muscle mass
  • Persons with pacemakers, cochlear implants, or other prohibitive conditions for magnetic resonance imaging
  • Atrial fibrillation
  • Patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol
  • Patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active AIDS, chronic lung disease requiring supplemental oxygen therapy and cirrhosis
  • Patients enrolled in interventional trials
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566670

United States, Tennessee
Vanderbilt University Medical Centet
Nashville, Tennessee, United States, 37232-2372
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University
Principal Investigator: Srinivasan Beddhu, M.D University of Utah
More Information

Responsible Party: Srinvasan Beddhu, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00566670     History of Changes
Other Study ID Numbers: IRB_00024816
R01DK077298 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2007    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016

Keywords provided by Srinvasan Beddhu, University of Utah:

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency