IV Insulin Protocol in Diabetes and Renal Transplantation
NCT ID: NCT00609986
Last Updated: 2013-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2007-07-31
2010-10-31
Brief Summary
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Hypothesis: It is hypothesized that intensive glycemic control will lead to better clinical and biochemical outcomes and improved long-term graft survival.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensive
The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
insulin
The intravenous regular insulin infusion will be delivered continuously during the transplant surgery and after surgery for a total of three days. While receiving the insulin infusion, the dose will be calculated to keep the blood sugar levels between 70-110 mg/dL.
After the regular insulin infusion is discontinued, the blood sugar levels will be measured by a finger stick blood glucose up to 5-6 times per day and the blood sugar levels will be corrected by a subcutaneous basal-bolus insulin injection for a blood sugar goal 70-110 mg/dL.
Upon discharge from the hospital, the patient will be placed on a basal-bolus regimen consisting of 3-4 insulin injections to maintain a blood sugar between 70-140.
Control
The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
NPH Insulin or glargine insulin and aspartame insulin
The NPH or glargine and aspartame insulin will be given subcutaneously using a small-short needle to administer the insulin.
The blood sugar level will be checked every 1 hour while in the operating room and treated with rapid-acting insulin as needed to keep the blood sugar levels 70-180 mg/dL. The blood sugar level will be checked every 4 hours when in the recovery room and on the 6 East transplant unit. Once the patient is able to eat, the blood sugar will be checked five times a day (before meals, at bedtime, and at 3:00 am). Long-acting and rapid-acting insulin will be used to maintain the target blood sugar level.
Upon discharge from the hospital, the patient will be placed on a minimum of one to two insulin injections to maintain a blood sugar between 90-180 mg/dL
Interventions
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insulin
The intravenous regular insulin infusion will be delivered continuously during the transplant surgery and after surgery for a total of three days. While receiving the insulin infusion, the dose will be calculated to keep the blood sugar levels between 70-110 mg/dL.
After the regular insulin infusion is discontinued, the blood sugar levels will be measured by a finger stick blood glucose up to 5-6 times per day and the blood sugar levels will be corrected by a subcutaneous basal-bolus insulin injection for a blood sugar goal 70-110 mg/dL.
Upon discharge from the hospital, the patient will be placed on a basal-bolus regimen consisting of 3-4 insulin injections to maintain a blood sugar between 70-140.
NPH Insulin or glargine insulin and aspartame insulin
The NPH or glargine and aspartame insulin will be given subcutaneously using a small-short needle to administer the insulin.
The blood sugar level will be checked every 1 hour while in the operating room and treated with rapid-acting insulin as needed to keep the blood sugar levels 70-180 mg/dL. The blood sugar level will be checked every 4 hours when in the recovery room and on the 6 East transplant unit. Once the patient is able to eat, the blood sugar will be checked five times a day (before meals, at bedtime, and at 3:00 am). Long-acting and rapid-acting insulin will be used to maintain the target blood sugar level.
Upon discharge from the hospital, the patient will be placed on a minimum of one to two insulin injections to maintain a blood sugar between 90-180 mg/dL
Eligibility Criteria
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Inclusion Criteria
* Diabetes diagnosis (Type 1 and Type 2, awaiting a living or cadaveric renal transplant, renal transplant candidates admitted to MUSC medical center for a donor kidney, FBG \>100 mg/dL per admission screening labs, random BG \>120mg/dL per admission screening labs, and
* Willing and able to provide informed consent
Exclusion Criteria
* Scheduled to receive a simultaneous pancreas transplant,
* History of a functioning pancreatic transplant,
* Patient currently managed on an insulin pump,
* Unable or unwilling to provide informed consent, and
* Unable to commit to the study protocol including the outpatient follow-up phase of care
18 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Responsible Party
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Kathie Hermayer
Professor
Principal Investigators
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Kathie L. Hermayer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina, Division of Endocrinology
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
Other Identifiers
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ADA 7-07-CR-22
Identifier Type: -
Identifier Source: secondary_id
HR #17383
Identifier Type: -
Identifier Source: org_study_id