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Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Total Parenteral Nutrition

Information source: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition

Intervention: Glargine Insulin (Drug); Regular insulin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: King Faisal Specialist Hospital & Research Center

Official(s) and/or principal investigator(s):
Hakeam A Hakeam, MS., BCPS, Principal Investigator, Affiliation: King Faisal Specialist Hospital & Research Centre


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.

Clinical Details

Official title: Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Total Parenteral Nutrition

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Achievement of target blood glucose (140 mg/dL to 200 mg/dL)

Secondary outcome: Developement of hypoglycemia ( blood glucose < 70 mg/dL)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

King Faisal Specialist Hospital & Research Centre, Riyadh 11211, Saudi Arabia; Recruiting
Abir H Omer, MD, Phone: +966 11 442 3657, Email: aomer@kfshrc.edu.sa
Hakeam A Hakeam, MS., BCPS, Principal Investigator
Additional Information

Study Site

Starting date: March 2013
Last updated: April 6, 2015

Page last updated: August 23, 2015

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