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

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Dietary Supplement: nutritional supplement; Drug: recombinant human growth hormone (rcGH); Behavioral: exercise

• Registration Number: NCT00244075
• Lead Sponsor: Vanderbilt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 2005-10-21
• Study First Submitted QC: 2005-10-21
• Study First Posted: 2005-10-25
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	nutritional supplement	nutrition supplementation, recombinant human growth hormone, and exercise
1	recombinant human growth hormone (rcGH)	nutrition supplementation, recombinant human growth hormone, and exercise
1	exercise	nutrition supplementation, recombinant human growth hormone, and exercise
2	nutritional supplement	nutrition supplementation only

Primary Outcome Measures

Name	Time	Method
net muscle protein balance	10 hours

Secondary Outcome Measures

Name	Time	Method
net whole body protein balance	10 hours

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States