Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
Information source: Vancouver General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Transplant Glucocorticoid Induced Diabetes
Intervention: Neutral protamine hagedorn (NPH) insulin (Drug); Regular human insulin or Insulin Aspart (Drug); Insulin glargine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Vancouver General Hospital Official(s) and/or principal investigator(s): Breay W Paty, MD, FRCPC, Principal Investigator, Affiliation: Vancouver General Hospital, University of British Columbia
Overall contact: Breay W Paty, MD, FRCPC, Phone: 604-875-5990, Email: breay.paty@vch.ca
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?
Clinical Details
Official title: Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Blood glucose - inpatient
Secondary outcome: Blood glucose - inpatientPost prandial blood glucose - inpatient Length of inpatient hospital stay Blood glucose Hemoglobin A1C Post prandial blood glucose Hypoglycemic episodes Glycemic treatment failure Cardiovascular events Post-transplant infections or new antibiotic use Transplant graft failure New acute renal failure Mortality
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Breay W Paty, MD, FRCPC, Phone: 604-875-5990, Email: breay.paty@vch.ca
Vancouver General Hospital - Jim Pattison Pavilion, Vancouver, British Columbia V5Z 1M9, Canada; Recruiting Breay W Paty, MD, FRCPC, Phone: 604-875-5990, Email: breay.paty@vch.ca David E Harris, MD, FRCPC, Phone: 778-995-5414, Email: deharris@interchange.ubc.ca Breay W Paty, MD, FRCPC, Principal Investigator
Additional Information
Multilingual dietary instructions to be distributed to ALL subjects during study from the Canadian Diabetes Association
Related publications: 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. 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. Review. 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. Review. 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. Review. 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.
Starting date: August 2012
Last updated: October 17, 2012
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