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

NCT00244075 | Completed Phase 2

• 1 other identifier: 9458
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• net muscle protein balance

  10 hours

Secondary Outcomes (1)

• net whole body protein balance

  10 hours

Study Arms (2)

1

ACTIVE COMPARATOR

nutrition supplementation, recombinant human growth hormone, and exercise

Dietary Supplement: nutritional supplement; Drug: recombinant human growth hormone (rcGH); Behavioral: exercise

2

ACTIVE COMPARATOR

nutrition supplementation only

Dietary Supplement: nutritional supplement

Interventions

nutritional supplement DIETARY_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

1; 2

recombinant human growth hormone (rcGH) DRUG

subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days

1

exercise BEHAVIORAL

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

• 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.

  PMID: 15213282 RESULT

• 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.

  PMID: 11739090 RESULT

• 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.

  PMID: 14678952 RESULT

• 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.

  PMID: 32390133 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Dietary Supplements; Growth Hormone; Exercise

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alp Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2005
• First Posted: October 25, 2005
• Study Start: July 1, 1998
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

US (1)