Sitagliptin in Non-Diabetic Patients Undergoing General Surgery
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Intervention: Sitagliptin; Placebo; Supplemental insulin (insulin lispro); Supplemental insulin (insulin aspart); Long acting basal insulin (insulin detemir); Long acting basal insulin (insulin glargine)
Intervention description: Participants will take 100 mg/day for patients with glomerular filtration rate (GFR) > 50 and 50 mg/day for GFR 30 - 49, beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.; Participants will take one pill daily beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.; Supplemental insulin lispro will be administered before meals, in addition to scheduled insulin dose, following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level.
For subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, the supplemental insulin scale is as follows:
BG between 181-220 mg/dL; 2-4 units of insulin lispro
BG between 221-260 mg/dL; 3-5 units of insulin lispro
BG between 261-300 mg/dL; 4-6 units of insulin lispro
BG between 301-350 mg/dL; 5-7 units of insulin lispro
BG between 351-400 mg/dL; 6-8 units of insulin lispro
BG > 400 mg/dL; 7-9 units of insulin lispro; Supplemental insulin aspart will be administered before meals, in addition to scheduled insulin dose, following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level.
For subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, the supplemental insulin scale is as follows:
BG between 181-220 mg/dL; 2-4 units of insulin lispro
BG between 221-260 mg/dL; 3-5 units of insulin lispro
BG between 261-300 mg/dL; 4-6 units of insulin lispro
BG between 301-350 mg/dL; 5-7 units of insulin lispro
BG between 351-400 mg/dL; 6-8 units of insulin lispro
BG > 400 mg/dL; 7-9 units of insulin lispro; Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change
Fasting and pre-meal BG between >180-240 mg/dl: increase detemir or glargine dose by 10% every day
Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight; Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change
Fasting and pre-meal BG between >180-240 mg/dl: increase detemir or glargine dose by 10% every day
Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Sitagliptin Phosphate; Insulin Aspart; Insulin Lispro; Insulin Detemir
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: stress hyperglycemia; blood glucose

Summary:

      The purpose of this study is to compare sitagliptin with a placebo for the prevention of high
      glucose after 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