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

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ClinicalTrials.gov Identifier: NCT00244075
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
End Stage Renal Disease Dietary Supplement: nutritional supplement Drug: recombinant human growth hormone (rcGH) Behavioral: exercise Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
Study Start Date : July 1998
Primary Completion Date : August 2006
Study Completion Date : August 2006

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. net muscle protein balance [ Time Frame: 10 hours ]

Secondary Outcome Measures :
  1. net whole body protein balance [ Time Frame: 10 hours ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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 Medical Center