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

NCT00566670 | Completed DMC

• 2 other identifiers: IRB_00024816R01DK077298
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Correlation of muscle mass with protein intake

  Mid-thigh muscle mass measured by magnetic resonance imaging

  Baseline and 18 months

Secondary Outcomes (1)

• Correlation of arterial stiffness with protein intake

  Baseline and 18 months

Study Arms (1)

Observation (all participants)

Stage 5 Chronic Kidney Disease and hemodialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

University of Utah Dialysis Program patients, and Vanderbilt University dialysis patients.

You may qualify if:

• Adult stage 5 chronic kidney disease patients, on dialysis for at least 3 months.
• Urine output \> 200 mL/day

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Vanderbilt University: collaborator

Study Sites (2)

Vanderbilt University Medical Centet

Nashville, Tennessee, 37232-2372, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

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.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Srinivasan Beddhu, M.D

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2007
• First Posted: December 3, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

US (2)