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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Dietary supplement: nutritional supplement; Drug: recombinant human growth hormone (rcGH); Behavioral: exercise

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
net muscle protein balance	10 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
net whole body protein balance	10 hours

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Alp Ikizler, MD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 1998
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: October 21, 2005
• First Submitted That Met QC Criteria: October 21, 2005
• First Posted (Estimate): October 25, 2005

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 9458 (Other Identifier: CTEP)