Clinical trial NCT02741687: Sitagliptin in Non-Diabetic Patients Undergoing General Surgery
Official title: Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia
Keywords: stress hyperglycemia
blood glucose
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Experiencing Stress Hyperglycemia
timeFrame: Up to time of discharge from hospital, an average of 10 days
Secondary outcomes:
measure: Number of Patients Requiring Supplemental, Subcutaneous Insulin
timeFrame: Up to time of discharge from hospital, an average of 10 days
measure: Total Daily Dose of Insulin for Patients Requiring Supplemental Insulin
timeFrame: Up to time of discharge from hospital, an average of 10 days
measure: Length of Hospital Stay
timeFrame: Up to time of discharge from hospital, an average of 10 days
measure: Number of Participants With Hypoglycemic Events
timeFrame: Up to time of discharge from hospital, an average of 10 days
measure: Number of Patients Transferred to the ICU Immediately After Surgery or During Hospitalization
timeFrame: Up to time of discharge from hospital, an average of 10 days
measure: Number of Days in the ICU
timeFrame: Up to time of discharge from hospital, an average of 10 days
measure: Number of Participants With Hospital Readmissions After Discharge
timeFrame: Up to 40 days (average time of discharge from the hospital plus 30 days)
measure: Number of Participants With Emergency Room Visits After Discharge
timeFrame: Up to 40 days (average time of discharge from the hospital plus 30 days)
measure: Number of Participants Experiencing Complications
timeFrame: Up to 40 days (average time of discharge from the hospital plus 30 days)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Maya Fayfman, MD
role: PRINCIPAL_INVESTIGATOR
References: