Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition Clinical Trial
— GLUCOSE-in-PNOfficial title:
Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)
Hyperglycemia increases the risk of complications in surgical patients. Focus on poor glycemic control as a contributor to adverse outcomes in settings outside the intensive care unit (ICU) is often dismissed. Total parenteral Nutrition (TPN) has been used in providing surgical patients with nutrition to prevent deterioration of nutritional status. However, many diabetic patients receiving TPN develop exaggerated hyperglycemia that requires frequent insulin administration via sliding scale. Providing diabetic patient's receiving TPN basal insulin is a known strategy to aid in blood sugar control and prevention of high blood sugar spikes. Many strategies for basal insulin provision have been utilized clinically during the administration of TPN; this includes the incorporation of insulin with TPN solution or administration of long acting insulin such as glargine. However, no study has compared any of these strategies aiming for selecting the optimum modality for controlling blood glucose in diabetic surgical patient's receiving TPN. We will conduct a study to compare the efficacy of once daily insulin glargine versus continuous regular insulin incorporated TPN in controlling blood glucose in non-critically ill diabetic surgical patients receiving TPN.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - All adult diabetic patients undergoing abdominal surgery operated by the surgical oncology team at KFSH & RC and required TPN therapy are possible subjects of the study. Exclusion Criteria: - Patients receiving octreotide or immunosuppressive agents including corticosteroids. - Recipient of < 3 units of regular insulin per day via subcutaneous insulin sliding scale after the third day of TPN recipient. - Patients with clinically relevant hepatic disease (> three times normal AST and ALT on admission to the hospital) or impaired renal function (GFR < 60 ml/min), history of diabetic ketoacidosis. Patients who get infected while on TPN as reflected with elevation of white blood cells and elevated temperature > 37.5 C will be excluded as well. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Saudi Arabia | King Faisal Specialist Hospital & Research Centre | Riyadh |
| Lead Sponsor | Collaborator |
|---|---|
| King Faisal Specialist Hospital & Research Center |
Saudi Arabia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Achievement of target blood glucose (140 mg/dL to 200 mg/dL) | Assessemnt of: Whole blood glucose every morning The amount of subcutenous insulin adminstraed via sliding scale every 6 hours. A target number of 60 patients to complete the study ( 30 patients in each arm) The achievement of target blood glucose based on whole blood glucose levels will be compared in two arms of the study for 5 days while on TPN. Also, the amount of insulin adminstred via sliding scale every day will be comapred as well |
2-years | No |
| Secondary | Developement of hypoglycemia ( blood glucose < 70 mg/dL) | To assess the development of hypoglycemia in both arms of the study | 2-years | Yes |