A Phase 2 interventional study of nutritional supplement and recombinant human growth hormone (rcGH) in End Stage Renal Disease, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-05-25.
Sponsored by Vanderbilt University · Phase 2, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 46 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
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Exclusion Criteria:
nutrition supplementation, recombinant human growth hormone, and exercise
Dietary Supplement: nutritional supplement · Drug: recombinant human growth hormone (rcGH) · Behavioral: exercise
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
subcutaneous administration of 75 micrograms/kg/day of rcGH for 3 consecutive days
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
net muscle protein balance
Time frame: 10 hours
net whole body protein balance
Time frame: 10 hours
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Vanderbilt University