Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN) (GLUCOSE-in-PN)

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition
• Intervention / Treatment: Drug: Glargine Insulin; Drug: Regular insulin

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11211
    • King Faisal Specialist Hospital & Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular Insulin incorporated in parenteral nutrition; Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk, will be added to parenteral nutrition to run over 24 hours as 80% of the total insulin requirement of the preceding day administered via subcutaneous sliding scale	Drug: Glargine Insulin; 80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine; Other Names: LANTUS (insulin glargine [rDNA origin] injection; Drug: Regular insulin; 80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours; Other Names: Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk
Active Comparator: Insulin glargine; Insulin glargine adminstred at daily night, calculated as 80% of the total insulin requirement of the preceding day from the insulin administered via subcutaneous sliding scale	Drug: Glargine Insulin; 80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine; Other Names: LANTUS (insulin glargine [rDNA origin] injection; Drug: Regular insulin; 80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours; Other Names: Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Developement of hypoglycemia ( blood glucose < 70 mg/dL)	To assess the development of hypoglycemia in both arms of the study	2-years

Collaborators and Investigators

• Sponsor: King Faisal Specialist Hospital & Research Center
• Investigators: Principal Investigator: Hakeam A Hakeam, MS., BCPS, King Faisal Specialist Hospital & Research Centre

Publications and helpful links

Helpful Links

• Study Site

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 14, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Hyperglycemia; Parenteral nutrition; Glargine insulin; Regular insulin
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: 2121166