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
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|
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
- 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 cardiovascular outcomes (arterial stiffness) in stage 5 CKD patients in hemodialysis is of great scientific and practical significance
|Study Type :||Observational|
|Actual Enrollment :||145 participants|
|Official Title:||Protein Intake, Nutrition and Cardiovascular Disease in Stage 5 Chronic Kidney Disease (CKD)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Observation (all participants)
Stage 5 Chronic Kidney Disease and hemodialysis patients
- Correlation of muscle mass with protein intake [ Time Frame: Baseline and 18 months ]Mid-thigh muscle mass measured by magnetic resonance imaging
- 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.
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|
|Principal Investigator:||Srinivasan Beddhu, M.D||University of Utah|