Clinical trial NCT01648218: Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
Official title: Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post-Transplant Glucocorticoid Induced Diabetes
Keywords: glucocorticoid
diabetes mellitus
post-transplant
insulin
Lead sponsor: Vancouver General Hospital
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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?


Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose - inpatient
timeFrame: Time (days) from enrollment to described treatment range, an expected average of 7 days
Secondary outcomes:
measure: Blood glucose - inpatient
timeFrame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days
measure: Post prandial blood glucose - inpatient
timeFrame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days
measure: Length of inpatient hospital stay
timeFrame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days
measure: Blood glucose
timeFrame: Enrollment to 3 months
measure: Hemoglobin A1C
timeFrame: Enrollment to 3 months
measure: Post prandial blood glucose
timeFrame: Enrollment to 3 months
measure: Hypoglycemic episodes
timeFrame: Enrollment to 3 months
measure: Glycemic treatment failure
timeFrame: Enrollment to 3 months
measure: Cardiovascular events
timeFrame: Enrollment to 3 months
measure: Post-transplant infections or new antibiotic use
timeFrame: Enrollment to 3 months
measure: Transplant graft failure
timeFrame: Enrollment to 3 months
measure: New acute renal failure
timeFrame: Enrollment to 3 months
measure: Mortality
timeFrame: Enrollment to 3 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Jim Pattison Pavilion
state: British Columbia
Study officials:
affiliation: Vancouver General Hospital, University of British Columbia
name: Breay W Paty, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Sarno G, Muscogiuri G, De Rosa P. New-onset diabetes after kidney transplantation: prevalence, risk factors, and management. Transplantation. 2012 Jun 27;93(12):1189-95. doi: 10.1097/TP.0b013e31824db97d.
citation: Griffith ML, Jagasia M, Jagasia SM. Diabetes mellitus after hematopoietic stem cell transplantation. Endocr Pract. 2010 Jul-Aug;16(4):699-706. doi: 10.4158/EP10027.RA.
citation: Lansang MC, Hustak LK. Glucocorticoid-induced diabetes and adrenal suppression: how to detect and manage them. Cleve Clin J Med. 2011 Nov;78(11):748-56. doi: 10.3949/ccjm.78a.10180.
citation: Umpierrez GE, Hellman R, Korytkowski MT, Kosiborod M, Maynard GA, Montori VM, Seley JJ, Van den Berghe G; Endocrine Society. Management of hyperglycemia in hospitalized patients in non-critical care setting: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012 Jan;97(1):16-38. doi: 10.1210/jc.2011-2098.