Protein Intake, Nutrition and Cardiovascular Diseases in Stage V CKD

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Vanderbilt University
Information provided by (Responsible Party):
Srinvasan Beddhu, University of Utah
ClinicalTrials.gov Identifier:
NCT00566670
First received: November 29, 2007
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition
Hemodialysis
End Stage Renal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protein Intake, Nutrition and Cardiovascular Disease in Stage V CKD on Hemodialysis

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 150
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)
Groups/Cohorts
Observation (all participants)
Chronic hemodialysis patients

Detailed Description:

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

  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 CV outcomes (arterial stiffness) in stage V CKD patients in hemodialysis is of great scientific and practical significance
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

115 patients from different dialysis centers in Utah and 35 patients from Vanderbilt University.

Criteria

Inclusion Criteria:

  • The study will be comprised of adult (≥18 years) chronic hemodialysis patients.
  • Appetite often change with initiation of dialysis and kidney function recover sometimes from acute renal failure; hence only patients on dialysis at least for three months will be included.
  • As urinary losses of urea could affect the estimation of protein intake from the urea kinetic modeling, we initially planned to exclude patients with urine output > 200 ml/day. However, this might exclude many potential participants. Therefore, we plan to include those participants with UPO > 200 ml/day but willing to collect 44-hr urine collection between dialysis treatments for measurement of urinary urea.

Exclusion Criteria:

  • Patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight will be excluded as hydration status might affect estimation of muscle mass. -
  • patients with inability to walk or those who use wheel-chair might have reduced mid-thigh muscle mass despite good protein intake because of disuse, and hence these patients will be excluded.
  • Persons with pacemakers and cochlear implants are excluded because of the magnetic field of MRI. Certain types of materials used in breast augmentation could be affected by the strong magnetic field and hence breast augmentation is an exclusion criteria. Artificial hips could interfere with mid-thigh muscle mass measurements whereas lumbar spine hardware could interfere with visceral fat measurements and hence, individuals with these will be excluded.-
  • Persons > 300 lbs will be excluded because of the weight limit of the MRI table. Atrial fibrillation could interfere with measurement of PWV.
  • 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 will be excluded.
  • 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 will be excluded.
  • Patients enrolled in interventional trials will be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566670

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
Vanderbilt University
Investigators
Principal Investigator: Srinivasan Beddhu, M.D University of Utah
  More Information

No publications provided

Responsible Party: Srinvasan Beddhu, MD, University of Utah
ClinicalTrials.gov Identifier: NCT00566670     History of Changes
Other Study ID Numbers: IRB_00024816, R01DK077298, 1 R01 DK077298
Study First Received: November 29, 2007
Last Updated: December 9, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 30, 2014