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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00592410 |
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.
Condition | Intervention | Phase |
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Acute Renal Failure |
Drug: human regular insulin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | The Effects of Intensive Insulin on Somatic and Visceral Protein Turnover in Acute Kidney Injury (AKI) |
Enrollment: | 0 |
Study Start Date: | February 2007 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: human regular insulin
administration 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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
New onset acute kidney injury (AKI) or AKI superimposed on chronic kidney disease. AKI will be defined as:
Exclusion Criteria:
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Principal Investigator: | Alp Ikizler, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University Medical Center ( Alp Ikizler, MD ) |
Study ID Numbers: | 061022 |
Study First Received: | December 18, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00592410 |
Health Authority: | United States: Institutional Review Board |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Acute Kidney Diseases |
Kidney Failure, Acute Insulin Kidney Failure |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |