Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery

Study Overview
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Brief Summary
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This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient population due to the effects on hepatic glucose production (a major feature of SH), safety (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and tolerability. The secondary objective of this study is to determine whether the management of patients with persistent insulin requirements following cardiac surgery differs among patients with stress hyperglycemia or mild diabetes.

Official Title
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Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery

Conditions
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Diabetes Mellitus, Type 2, Hyperglycemia

Intervention / Treatment
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* Drug: Sitagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia AND: Cardiac Surgery Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose >150 mg/dL at least twice in a 24 hour period (>4 hours apart) and otherwise not requiring basal insulin Exclusion Criteria: use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours left ventricular assist device percutaneous or laparoscopic surgery end stage renal disease end stage liver disease history of pancreatitis type 1 diabetes pregnancy unable to give consent in english no phone prisoners less than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br>Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge | Drug: Sitagliptin<br>* Sitagliptin prior to hospital discharge and 6 weeks following discharge.<br>* Other names: Januvia;|
| Placebo Comparator: Placebo<br>Patients will receive placebo prior to discharge and 6 weeks after discharge. | Drug: Placebo<br>* Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Fasting Glucose | Difference in mean fasting glucose at 6 weeks post-discharge. | 6 weeks |