Sitagliptin in Non-Diabetic Patients Undergoing General Surgery

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Treatments: Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Sitagliptin Phosphate

Criteria

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