Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT00592410

The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI)

Status
Withdrawn
Phase
Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Vanderbilt University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

We propose to determine the acute metabolic effects of intensive insulin therapy when administered to AKI patients with a particular focus on its effects on protein metabolism. We hypothesize that the degree of insulin resistance correlates with protein catabolism in critically ill patients with AKI, and that intensive insulin therapy will result in substantial reductions in both whole-body and skeletal muscle protein breakdown thereby improving overall protein balance. We also hypothesize that this therapy will have favorable effects on the inflammatory and oxidative stress profile of patients with AKI. The metabolic response to these interventions will be assessed through stable isotope infusion techniques, allowing for the most precise assessment of protein and energy homeostasis.

Conditions

Interventions

TypeNameDescription
DRUGhuman regular insulinadministration of a primed continuous infusion of human regular insulin at a rate of 2.0 mU/kg/min while maintaining the plasma glucose level at 100 mg/dl via adjusting a variable infusion of 50% dextrose (i.e., a hyperinsulinemic euglycemic blood glucose clamp); duration of 3 hours; performed concomitantly with amino acid supplementation

Timeline

Start date
2007-02-01
Primary completion
2008-11-01
Completion
2008-11-01
First posted
2008-01-14
Last updated
2011-08-05

Source: ClinicalTrials.gov record NCT00592410. Inclusion in this directory is not an endorsement.