Protein Intake, Nutrition and Cardiovascular Diseases in Stage V CKD
We do not know whether consumption of high amounts of protein in dialysis patients is beneficial or harmful. We will assess how much of protein patients take over three days and how that correlates with their muscle mass and arterial stiffness.
End Stage Renal Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Protein Intake, Nutrition and Cardiovascular Disease in Stage V CKD on Hemodialysis|
- We will assess in our patients how the amount of their protein intake correlates with their muscle mass and arterial stiffness. [ Time Frame: Baseline,6 months,12 months,18 months ] [ Designated as safety issue: No ]
- Evidence of clinically definite arterial stiffness and cardio vascular disease confirmed by a MRI/BIA test/PWV test [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
We will draw 30 ml of blood 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.
|Study Start Date:||September 2007|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Observation (all participants)
Chronic hemodialysis patients
Even though the National Kidney Foundation guidelines recommend a dietary protein intake of 1.2 g/kg/d in hemodialysis patients, it remains unclear whether high protein intake has beneficial or harmful nutritional and cardiovascular effects in this population.
We hypothesize 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 g/day) or dietary protein intake normalized to body weight (DPI in g/kg/day) with
- Nutritional status (mid-thigh muscle mass as measured by Magnetic Resonance Imaging ) and functional status (6-min walk) and
- Arterial stiffness (aortic pulse wave velocity) Understanding the relationship between protein intake with body composition (muscle mass) and intermediate CV outcomes (arterial stiffness) in stage V CKD patients in hemodialysis is of great scientific and practical significance
Please refer to this study by its ClinicalTrials.gov identifier: 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|
|Principal Investigator:||Srinivasan Beddhu, M.D||University of Utah|