Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nutritional supplement
recombinant human growth hormone (rcGH)
exercise
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility 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
Sites / Locations
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
nutrition supplementation, recombinant human growth hormone, and exercise
nutrition supplementation only
Outcomes
Primary Outcome Measures
net muscle protein balance
Secondary Outcome Measures
net whole body protein balance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00244075
Brief Title
Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
Official Title
Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
nutrition supplementation, recombinant human growth hormone, and exercise
Arm Title
2
Arm Type
Active Comparator
Arm Description
nutrition supplementation only
Intervention Type
Dietary Supplement
Intervention Name(s)
nutritional supplement
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
recombinant human growth hormone (rcGH)
Intervention Description
subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
net muscle protein balance
Time Frame
10 hours
Secondary Outcome Measure Information:
Title
net whole body protein balance
Time Frame
10 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15213282
Citation
Pupim LB, Flakoll PJ, Ikizler TA. Nutritional supplementation acutely increases albumin fractional synthetic rate in chronic hemodialysis patients. J Am Soc Nephrol. 2004 Jul;15(7):1920-6. doi: 10.1097/01.asn.0000128969.86268.c0.
Results Reference
result
PubMed Identifier
11739090
Citation
Ikizler TA, Pupim LB, Brouillette JR, Levenhagen DK, Farmer K, Hakim RM, Flakoll PJ. Hemodialysis stimulates muscle and whole body protein loss and alters substrate oxidation. Am J Physiol Endocrinol Metab. 2002 Jan;282(1):E107-16. doi: 10.1152/ajpendo.2002.282.1.E107.
Results Reference
result
PubMed Identifier
14678952
Citation
Pupim LB, Flakoll PJ, Levenhagen DK, Ikizler TA. Exercise augments the acute anabolic effects of intradialytic parenteral nutrition in chronic hemodialysis patients. Am J Physiol Endocrinol Metab. 2004 Apr;286(4):E589-97. doi: 10.1152/ajpendo.00384.2003. Epub 2003 Dec 16.
Results Reference
result
PubMed Identifier
32390133
Citation
Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
Results Reference
derived
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Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
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