Diabetes Mellitus
Conditions
Keywords
post-transplant, diabetes mellitus, renal transplant, kidney transplant, lung transplant, heart transplant, insulin
Brief summary
To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).
Detailed description
A large percentage of organ transplant recipients develop de novo diabetes mellitus after transplantation, also called New Onset Diabetes After Transplant or NODAT. The cause of the diabetes appears to be commonly used anti-rejection medications, particularly calcineurin inhibitors and glucocorticoids. Management of glucose levels in NODAT often requires insulin therapy. Standard practice is to start long-acting insulin. However, patients with NODAT often exhibit fasting morning glucose levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. This seems to make NODAT patients more susceptible to fasting, or morning, hypoglycemia on long-acting insulin analogues than non-transplant patients with type II diabetes. This phenomenon of morning hypoglycemia in NODAT often limits the up-titration of basal insulin resulting in suboptimal treatment of hyperglycemia later in the day. Because of this pattern, transplant patients may respond better to morning insulin isophane (intermediate acting) than to long-acting insulin glargine preparations. Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin A1c (glycosylated hemoglobin).
Interventions
DRUGInsulin, Isophane
daily dosing based on fasting morning glucose levels
DRUGinsulin glargine
daily dose based on fasting morning glucose levels
Sponsors
Inova Health Care Services
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Subjects will be randomized to 1. Insulin glargine (Lantus) or 2. Insulin isophane (NPH)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must be followed by the Inova Fairfax Hospital transplantation program for post-transplant care 2. Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin hypoglycemic medication 3. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if it was required) 4. Ability to read consent form and give consent in English.
Exclusion criteria
1. Use of insulin or non-insulin hypoglycemic medication before transplantation 2. Cystic fibrosis patients 3. Age \< 18 years of age 4. Pregnancy 5. Non-English speaking subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Hemoglobin A1C (Glycosylated Hemoglobin) | at 6 months post enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Glucose Values | 3 and 6 months post enrollment | measured by continuous glucose monitoring for 5 days |
Countries
United States
Participant flow
Recruitment details
Medical Clinic
Participants by arm
| Arm | Count |
|---|---|
| Insulin Isophane daily dose will be titrated based on fasting morning glucose values
Insulin, Isophane: daily dosing based on fasting morning glucose levels | 0 |
| Insulin Glargine daily dose will be titrated based on fasting morning glucose values
insulin glargine: daily dose based on fasting morning glucose levels | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated early | 0 | 1 |
Baseline characteristics
| Characteristic | Insulin Isophane | Insulin Glargine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| basal insulin types administered | — | 1 basal insulin type | 1 basal insulin type |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | — | 1 Participants | 1 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
Change in Hemoglobin A1C (Glycosylated Hemoglobin)
Time frame: at 6 months post enrollment
Population: study terminated early
Secondary
Mean Blood Glucose Values
measured by continuous glucose monitoring for 5 days
Time frame: 3 and 6 months post enrollment
Population: No data study did not complete