Clinical trial NCT02216799: Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)
Official title: Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition
Keywords: Parenteral nutrition
Hyperglycemia
Glargine insulin
Regular insulin
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Achievement of target blood glucose (140 mg/dL to 200 mg/dL)
timeFrame: 2-years
Secondary outcomes:
measure: Developement of hypoglycemia ( blood glucose < 70 mg/dL)
timeFrame: 2-years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Centre
Study officials:
affiliation: King Faisal Specialist Hospital & Research Center
name: Hakeam A Hakeam, MS., BCPS
role: PRINCIPAL_INVESTIGATOR
References: