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

Kathleen Dungan

Status and phase

Terminated

Phase 4

Conditions

Hyperglycemia

Diabetes Mellitus, Type 2

Treatments

Drug: Sitagliptin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01970462

2013H0328

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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