Clinical trial NCT00566670: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: Hemodialysis
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Vanderbilt University
First posted: 2007-12-03
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Utah Dialysis Program patients, and Vanderbilt University dialysis patients.

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

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

Primary outcomes:
measure: Correlation of muscle mass with protein intake
timeFrame: Baseline and 18 months
Secondary outcomes:
measure: Correlation of arterial stiffness with protein intake
timeFrame: Baseline and 18 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Centet
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Srinivasan Beddhu, M.D
role: PRINCIPAL_INVESTIGATOR
References: