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IV Insulin Protocol in Diabetes and Renal Transplantation

Medical University of South Carolina (MUSC) logo

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Diabetes
Hyperglycemia
Kidney Transplantation

Treatments

Drug: insulin
Drug: NPH Insulin or glargine insulin and aspartame insulin

Study type

Interventional

Funder types

Other

Identifiers

NCT00609986
ADA 7-07-CR-22
HR #17383

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Intensive
Experimental group
Description:
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.
Treatment:
Drug: insulin
Control
Active Comparator group
Description:
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.
Treatment:
Drug: NPH Insulin or glargine insulin and aspartame insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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