Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Blood glucose - inpatient
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have undergone bone marrow, liver, lung, or renal transplant.
- •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.
- •Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below:
- •Fasting plasma glucose ≥7.0 mmol/L (repeated x 1)
- •Any plasma glucose ≥11.0 mmol/L
- •Have at least three pre-meal inpatient capillary blood glucose (CBG) readings ≥ 7.8 mmol/L
- •Be eating meals by mouth
排除标准
- •Heart, Pancreas, Islet cell transplant recipients
- •Previous use of Basal-Bolus or Pre-Mixed Insulin regimen
- •Diabetes mellitus type I
- •NPO (not eating meals by mouth)
- •Receiving enteral (tube feeds) or parenteral (TPN) nutrition
研究组 & 干预措施
Neutral protamine hagedorn (NPH) insulin
Drug: 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.
干预措施: Neutral protamine hagedorn (NPH) insulin (Drug)
Regular or Aspart insulin
Drug: 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.
干预措施: Regular human insulin or Insulin Aspart (Drug)
Insulin glargine
Drug: 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.
干预措施: Insulin glargine (Drug)
结局指标
主要结局
Blood glucose - inpatient
时间窗: Time (days) from enrollment to described treatment range, an expected average of 7 days
Mean time from baseline to achieve at least 80% of pre-meal capillary blood glucose values within 5.0 - 7.8 mmol/L over a 48 hour period during hospitalization
次要结局
- Blood glucose(Enrollment to 3 months)
- Blood glucose - inpatient(Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days)
- Length of inpatient hospital stay(Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days)
- Glycemic treatment failure(Enrollment to 3 months)
- Post-transplant infections or new antibiotic use(Enrollment to 3 months)
- New acute renal failure(Enrollment to 3 months)
- Post prandial blood glucose - inpatient(Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days)
- Hemoglobin A1C(Enrollment to 3 months)
- Post prandial blood glucose(Enrollment to 3 months)
- Hypoglycemic episodes(Enrollment to 3 months)
- Transplant graft failure(Enrollment to 3 months)
- Cardiovascular events(Enrollment to 3 months)
- Mortality(Enrollment to 3 months)
研究者
David E. Harris, MD
MD, FRCPC, Clinical Endocrinology Fellow, University of British Columbia
Vancouver General Hospital