NCT Number: NCT02741687
The purpose of this study is to compare sitagliptin with a placebo for the prevention of high glucose after general surgery.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Emory University Hospital Midtown, Atlanta, Georgia, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Januvia
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:
Other names: Humalog
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:
Other names: NovoLog
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:
Other names: Levemir
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:
Other names: Lantus
Time frame: Up to time of discharge from hospital, an average of 10 days
The number of participants with at least one episode of stress hyperglycemia. Stress hyperglycemia is defined as a blood glucose > 180 mg/dL.
Time frame: Up to time of discharge from hospital, an average of 10 days
Number of patients requiring subcutaneous insulin, either sliding scale insulin or basal insulin
Time frame: Up to time of discharge from hospital, an average of 10 days
Total daily dose of insulin for patients requiring supplemental insulin during surgery and recovery in participants receiving sitagliptin and those receiving the placebo
Time frame: Up to time of discharge from hospital, an average of 10 days
Total length of hospital stay
Time frame: Up to time of discharge from hospital, an average of 10 days
Number of participants experiencing at least one episode of mild hypoglycemia (blood glucose < 70 mg/dL) or clinically significant hypoglycemia (blood glucose < 54 mg/dL)
Time frame: Up to time of discharge from hospital, an average of 10 days
The number of patients who were transferred to the ICU immediately following surgery or anytime while hospitalized after surgery.
Time frame: Up to time of discharge from hospital, an average of 10 days
The number of days a participant spent in the ICU following surgery, when transfer to the ICU was required.
Time frame: Up to 40 days (average time of discharge from the hospital plus 30 days)
Readmissions to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any hospital readmissions to hospitals other than the one where the surgery occurred are not known.
Time frame: Up to 40 days (average time of discharge from the hospital plus 30 days)
Emergency room visits to the study hospital occurring within 30 days of hospital discharge were documented. There were no follow up phone calls or appointments with participants so any emergency room visits to hospitals other than the one where the surgery occurred are not known.
Time frame: Up to 40 days (average time of discharge from the hospital plus 30 days)
The number of subjects who experience complications including: wound infection, respiratory failure, pneumonia, acute kidney injury with a rise in creatinine by 38 micromoles/Liter from baseline, major adverse cardiac events, bacterial septic infection, and death. Participants will be followed for 30 days following hospital discharge and all complications will be documented.
Emory University
Other
Prevention of Stress Hyperglycemia With the Use of DPP-4 Inhibitors in Non-diabetic Patients Undergoing Non-cardiac Surgery, a Pilot Study
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