Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00244075
First received: October 21, 2005
Last updated: December 19, 2007
Last verified: December 2007
  Purpose

The goal of this study is to evaluate the metabolic effects of concomitant use of three consecutive doses of recombinant human growth hormone over three days and exercise during continuous nutrient infusion in chronic hemodialysis patients. We would also like to evaluate the metabolic effects of nutritional supplementation alone without the additional anabolic strategies.


Condition Intervention Phase
End Stage Renal Disease
Dietary Supplement: nutritional supplement
Drug: recombinant human growth hormone (rcGH)
Behavioral: exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • net muscle protein balance [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • net whole body protein balance [ Time Frame: 10 hours ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 1998
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
nutrition supplementation, recombinant human growth hormone, and exercise
Dietary Supplement: nutritional supplement
either oral nutritional formula (Nepro) or intravenous IDPN solution will be administered during hemodialysis; Nepro has a total calorie amount as well as protein, carbohydrate and fat content that are comparable to that of IDPN, and will be provided at four equal amounts with 1-hour intervals throughout the study (150 ml for a total of 600 ml over 4 hours of hemodialysis); IDPN consists of 225 ml of amino acids at a concentration of 15%, 112.5 ml of dextrose at 50% and 112.5 ml of lipids at 20%, will be given at a rate of 150 ml/hr, and will provide 209 kcal/hr
Drug: recombinant human growth hormone (rcGH)
subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days
Behavioral: exercise
either dual leg press (3 sets of 8-12 repetitions) beginning 30 minutes prior to hemodialysis, or modified stepper (minimum of 15 minutes up to a maximum of 90 minutes, depending upon the patient's tolerance) beginning 15 minutes post initiation of hemodialysis
Active Comparator: 2
nutrition supplementation only
Dietary Supplement: nutritional supplement
either oral nutritional formula (Nepro) or intravenous IDPN solution will be administered during hemodialysis; Nepro has a total calorie amount as well as protein, carbohydrate and fat content that are comparable to that of IDPN, and will be provided at four equal amounts with 1-hour intervals throughout the study (150 ml for a total of 600 ml over 4 hours of hemodialysis); IDPN consists of 225 ml of amino acids at a concentration of 15%, 112.5 ml of dextrose at 50% and 112.5 ml of lipids at 20%, will be given at a rate of 150 ml/hr, and will provide 209 kcal/hr

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On hemodialysis for more than 6 months, on a thrice weekly hemodialysis program;
  • Adequately dialyzed (Kt/V > 1.4).

Exclusion Criteria:

  • Patients unable to perform exercise.
  • Pregnant women.
  • Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
  • Patients hospitalized within the last month prior to the study.
  • Patients with recirculation detected on the AV graft.
  • Patients receiving steroids and/or other immunosuppressive agents
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00244075

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Alp Ikizler, MD Vanderbilt University
  More Information

Publications:
Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00244075     History of Changes
Other Study ID Numbers: 9458
Study First Received: October 21, 2005
Last Updated: December 19, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Nutrition Disorders
Malnutrition
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014