Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study

The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.

Approximately 30-40% of hospitalized patients will develop stress hyperglycemia (high glucose in response to surgery or illness). High glucose is linked to an increased risk of hospital complications including wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. Recent studies have found that inpatient therapy with oral dipeptidyl peptidase-4 inhibitor (DPP4-I) is an effective alternative to insulin in improving glycemic control with low risk of hypoglycemia in general medicine and surgical patients.

Sitagliptin is an oral medication approved by the Food and Drug Administration (FDA) to treat patients with diabetes. The aim of this study is to determine whether treatment with sitagliptin once daily can prevent the development of stress hyperglycemia during the postoperative period in non-diabetic patients undergoing general surgery.

Inclusion Criteria:

• Undergoing non-cardiac surgery
• No previous history of diabetes or hyperglycemia
• Fasting blood glucose level of <126 mg/dl
• Blood glucose <126mg/dl at the time of randomization (could occur at any time of the day)

Exclusion Criteria:

• History of hyperglycemia (blood glucose equal to or above 126 mg/dl or HbA1C greater than 6.5%) or previous treatment with oral antidiabetic agents or insulin
• Patients undergoing cardiac surgery
• Patients anticipated to require ICU care following surgery
• Severely impaired renal function (GFR < 30 ml/min) or clinically significant hepatic failure
• Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
• Patients with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction
• Patients with clinically relevant pancreatic or gallbladder disease
• Treatment with oral (> 5 mg/day) or injectable corticosteroid
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Pregnancy or breast-feeding at time of enrollment