End Stage Renal Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTnutritional 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
DRUGrecombinant human growth hormone (rcGH)
subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days
BEHAVIORALexercise
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
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| net muscle protein balance | 10 hours |
Secondary
| Measure | Time frame |
|---|---|
| net whole body protein balance | 10 hours |
Countries
United States
Outcome results
None listed