Diabetes, Hyperglycemia, Kidney Transplantation
Conditions
Keywords
Kidney, Transplantation, Diabetes, Hyperglycemia
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.
Interventions
DRUGinsulin
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.
DRUGNPH 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
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delayed Graft Function | 10 days | 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. |
| Acute/Active Rejection | 30 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe Hypoglycemia | 30 months | Blood glucose less than 40 mg/dl |
| Severe Hyperglycemia | 30 months | Blood glucose greater than 350 mg/dl. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from the Medical University of South Carolina prior to receiving a renal transplant.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 44 |
| 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. | 49 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not receive transplant or treatment | 8 | 3 |
Baseline characteristics
| Characteristic | Control | Total | Intensive |
|---|---|---|---|
| Age Continuous | 56.3 years STANDARD_DEVIATION 9.6 | 57.7 years STANDARD_DEVIATION 9.7 | 58 years STANDARD_DEVIATION 9.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 56 Participants | 28 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 33 Participants | 15 Participants |
| Sex: Female, Male Female | 14 Participants | 28 Participants | 14 Participants |
| Sex: Female, Male Male | 35 Participants | 65 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 44 | 14 / 49 |
| serious Total, serious adverse events | 0 / 44 | 1 / 49 |
Outcome results
Primary
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.
Time frame: 30 months
Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive | Acute/Active Rejection | 9 participants |
| Control | Acute/Active Rejection | 2 participants |
Primary
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.
Time frame: 10 days
Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive | Delayed Graft Function | 8 participants |
| Control | Delayed Graft Function | 12 participants |
Secondary
Severe Hyperglycemia
Blood glucose greater than 350 mg/dl.
Time frame: 30 months
Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive | Severe Hyperglycemia | 5 participants |
| Control | Severe Hyperglycemia | 12 participants |
Secondary
Severe Hypoglycemia
Blood glucose less than 40 mg/dl
Time frame: 30 months
Population: The intent-to-treat analysis set consisted of the participants that underwent a renal transplant.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intensive | Severe Hypoglycemia | 7 participants |
| Control | Severe Hypoglycemia | 2 participants |