Effects of Nutritional Supplementation on Protein and Energy Homeostasis in Malnourished Chronic Hemodialysis Patients
Overview
- Phase
- Phase 2
- Intervention
- nutritional supplement
- Conditions
- End Stage Renal Disease
- Sponsor
- Vanderbilt University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- net muscle protein balance
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Alp Ikizler
Professor
Vanderbilt University
Eligibility Criteria
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
Arms & Interventions
1
nutrition supplementation, recombinant human growth hormone, and exercise
Intervention: nutritional supplement
1
nutrition supplementation, recombinant human growth hormone, and exercise
Intervention: recombinant human growth hormone (rcGH)
1
nutrition supplementation, recombinant human growth hormone, and exercise
Intervention: exercise
2
nutrition supplementation only
Intervention: nutritional supplement
Outcomes
Primary Outcomes
net muscle protein balance
Time Frame: 10 hours
Secondary Outcomes
- net whole body protein balance(10 hours)