IV Insulin Protocol in Diabetes and Renal Transplantation

NCT00609986 | Completed Results DMC

• 2 other identifiers: HR #17383ADA 7-07-CR-22
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Diabetes; Hyperglycemia

Keywords

Kidney; Transplantation; Diabetes; Hyperglycemia

Outcome Measures

Primary Outcomes (2)

• Delayed Graft Function

  Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl.

  10 days

• Acute/Active Rejection

  Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology.

  30 months

Secondary Outcomes (2)

• Severe Hypoglycemia

  30 months

• Severe Hyperglycemia

  30 months

Study Arms (2)

Intensive

EXPERIMENTAL

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.

Drug: insulin

Control

ACTIVE COMPARATOR

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.

Drug: NPH Insulin or glargine insulin and aspartame insulin

Interventions

insulin DRUG

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.

Intensive

NPH Insulin or glargine insulin and aspartame insulin DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and greater,
• 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

You may not qualify if:

• History of an active GI bleed in the previous 3 mos,
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29464, United States

Location

Related Publications (2)

• 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.

  PMID: 37526194 DERIVED

• 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.

  PMID: 32803882 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hyperglycemia

Interventions

Insulin; Insulin, Isophane; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Limitations and Caveats

A limitation of the trial was that the majority of the patients enrolled in the study were African American, and therefore the findings cannot be extended to groups of other ethnic groups.

Results Point of Contact

• Title: Dr. Kathie Hermayer
• Organization: Medical University of South Carolina

hermayer@musc.edu

843-792-2529

Study Officials

• Kathie L. Hermayer, MD, MS

  Medical University of South Carolina, Division of Endocrinology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2008
• First Posted: February 7, 2008
• Study Start: July 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 6, 2013
• Results First Posted: August 7, 2013

Record last verified: 2013-08

Locations

US (1)