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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

nutrition supplementation, recombinant human growth hormone, and exercise

Group Type ACTIVE_COMPARATOR

nutritional supplement

Intervention Type 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

recombinant human growth hormone (rcGH)

Intervention Type DRUG

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

exercise

Intervention Type 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

2

nutrition supplementation only

Group Type ACTIVE_COMPARATOR

nutritional supplement

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

recombinant human growth hormone (rcGH)

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

Intervention Type DRUG

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No