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

• ClinicalTrials.gov Identifier: NCT00566670
• Recruitment Status: Completed
• First Posted: December 3, 2007
• Last Update Posted: August 11, 2016
• Sponsor: University of Utah
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Vanderbilt University
• Information provided by (Responsible Party): Srinvasan Beddhu, University of Utah

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
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Groups and Cohorts

Group/Cohort
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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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.

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

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Srinivasan Beddhu, M.D; University of Utah

More Information

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

Keywords provided by Srinvasan Beddhu, University of Utah:

Hemodialysis

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency