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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
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah

Tracking Information
First Submitted Date November 29, 2007
First Posted Date December 3, 2007
Last Update Posted Date August 11, 2016
Study Start Date September 2007
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 9, 2016)
Correlation of muscle mass with protein intake [ Time Frame: Baseline and 18 months ]
Mid-thigh muscle mass measured by magnetic resonance imaging
Original Primary Outcome Measures
 (submitted: November 30, 2007)
  • MRI for mid-thigh muscle mass ( Baseline,6,18 months) [ Time Frame: Baseline,6 months,12 months,18 months ]
  • DEXA and BIA Scans [ Time Frame: Baseline,6 months,12 months,18 months ]
  • Pulse wave analysis and aortic pulse wave velocity [ Time Frame: Baseline,6 months,12 months,18 months ]
Change History
Current Secondary Outcome Measures
 (submitted: August 9, 2016)
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
Original Secondary Outcome Measures
 (submitted: November 30, 2007)
Anthropometry- 6-min walk- Chair presses [ Time Frame: At basline ,6month,12month,18month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Protein, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease
Official Title Protein Intake, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease (CKD)
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

Sampling Method Non-Probability Sample
Study Population University of Utah Dialysis Program patients, and Vanderbilt University dialysis patients.
Condition End Stage Renal Disease
Intervention Not Provided
Study Groups/Cohorts Observation (all participants)
Stage 5 Chronic Kidney Disease and hemodialysis patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 9, 2016)
145
Original Estimated Enrollment
 (submitted: November 30, 2007)
150
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00566670
Other Study ID Numbers IRB_00024816
R01DK077298 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Srinvasan Beddhu, University of Utah
Study Sponsor University of Utah
Collaborators
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Vanderbilt University
Investigators
Principal Investigator: Srinivasan Beddhu, M.D University of Utah
PRS Account University of Utah
Verification Date August 2016