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

Study Overview
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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.

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

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Dietary Supplement: nutritional supplement
* Drug: recombinant human growth hormone (rcGH)
* Behavioral: exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>nutrition supplementation, recombinant human growth hormone, and exercise | Dietary Supplement: nutritional supplement<br>* 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<br>Drug: recombinant human growth hormone (rcGH)<br>* subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days<br>Behavioral: exercise<br>* 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<br>|
| Active Comparator: 2<br>nutrition supplementation only | Dietary Supplement: nutritional supplement<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| net muscle protein balance |  | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| net whole body protein balance |  | 10 hours |