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

Vanderbilt University

Status and phase

Completed

Phase 2

Conditions

End Stage Renal Disease

Treatments

Dietary Supplement: nutritional supplement

Drug: recombinant human growth hormone (rcGH)

Behavioral: exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00244075

9458

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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