Post-Transplant Glucocorticoid Induced Diabetes | Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
Post-Transplant Glucocorticoid Induced Diabetes research study
What is the primary objective of this study?
No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective: - Group 1: Intermediate-acting (NPH) insulin at breakfast - Group 2: Short-acting insulin (regular or aspart) before meals - Group 3: Insulin glargine at breakfast Question/Hypothesis: Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?
Who is eligible to participate?
Inclusion Criteria: 1. Have undergone bone marrow, liver, lung, or renal transplant. 2. Be using once daily oral glucocorticoid therapy (total daily dose of Prednisone ≥10 mg, Hydrocortisone ≥40 mg, Dexamethasone ≥1.5 mg) administered in the morning and expected to continue for at least 2 weeks. 3. Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below: 1. Fasting plasma glucose ≥7.0 mmol/L (repeated x 1) 2. Any plasma glucose ≥11.0 mmol/L 4. Have at least three pre-meal inpatient capillary blood glucose (CBG) readings ≥ 7.8 mmol/L 5. Be eating meals by mouth Exclusion Criteria: 1. Heart, Pancreas, Islet cell transplant recipients 2. Previous use of Basal-Bolus or Pre-Mixed Insulin regimen 3. Diabetes mellitus type I 4. NPO (not eating meals by mouth) 5. Receiving enteral (tube feeds) or parenteral (TPN) nutrition
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Post-Transplant Glucocorticoid Induced Diabetes
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Neutral protamine hagedorn (NPH) insulin
Drug:Regular human insulin or Insulin Aspart
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Neutral protamine hagedorn (NPH) insulinDrug: Neutral protamine hagedorn (NPH) insulin Other Names: Humulin N, Novolin N Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 12 hours; for duration subjects are concurrently administered once-daily glucocorticoid.
Regular or Aspart insulinDrug: Regular human insulin or Insulin Aspart Other Names: Humulin R, Novolin R, Novolog, NovoRapid Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before meals; Duration: 2 hours (Aspart) or 6 hours (Regular); for duration subjects are concurrently administered once-daily glucocorticoid.
Insulin glargineDrug: Insulin glargine Other Names: Lantus Route: Subcutaneous; Dosage: No fixed dose, varies between subjects; Frequency: daily before breakfast; Duration: 24 hours; for duration subjects are concurrently administered once-daily glucocorticoid.
Start Date: August 2012
Completed Date: June 2013
Phase: Phase 4
Primary Outcome: Blood glucose - inpatient
Secondary Outcome: Blood glucose - inpatient
Study sponsors, principal investigator, and references
Principal Investigator: Breay W Paty, MD, FRCPC
Lead Sponsor: Vancouver General Hospital
Lane JT, Dagogo-Jack S. Approach to the patient with new-onset diabetes after transplant (NODAT). J Clin Endocrinol Metab. 2011 Nov;96(11):3289-97. doi: 10.1210/jc.2011-0657.