Viewing Study NCT00609986



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Last Modification Date: 2024-10-26 @ 9:44 AM
Study NCT ID: NCT00609986
Status: COMPLETED
Last Update Posted: 2013-09-06
First Post: 2008-01-02

Brief Title: IV Insulin Protocol in Diabetes and Renal Transplantation
Sponsor: Medical University of South Carolina
Organization: Medical University of South Carolina

Study Overview

Official Title: Intravenous Insulin Protocol in Diabetes and Renal Transplantation Study
Status: COMPLETED
Status Verified Date: 2013-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Purpose The purpose of this study is to provide tight blood sugar control using insulin given through the veins at the time of kidney transplantation and up to 3 days after surgery After release from the hospital the patient will control blood sugar with subcutaneous insulin injections or pills With this approach outcomes should improve for diabetic transplant patients such as longer life of the new kidney fewer hospital readmissions decreased associated infections and other advantages

Hypothesis It is hypothesized that intensive glycemic control will lead to better clinical and biochemical outcomes and improved long-term graft survival
Detailed Description: Research Design A randomized control trial comparing intensive intravenous insulin IVI for use in the hospital followed by intensive subcutaneous sc insulin use for in-patient and out-patient glycemic control will be conducted

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
ADA 7-07-CR-22 None None None