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

NCT ID: NCT02216799

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2015-08-31

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.

Conditions

Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Glargine Insulin

Intervention Type: DRUG

80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine

Regular insulin

Intervention Type: DRUG

80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours

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

Group Type: ACTIVE_COMPARATOR

Glargine Insulin

Intervention Type: DRUG

80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine

Regular insulin

Intervention Type: DRUG

80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours

Interventions

Glargine Insulin

80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

LANTUS (insulin glargine [rDNA origin] injection; Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hakeam A Hakeam, MS., BCPS

Role: PRINCIPAL_INVESTIGATOR

King Faisal Specialist Hospital & Research Center

Locations

King Faisal Specialist Hospital & Research Centre

Riyadh, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Related Links

http://www.kfshrc.edu.sa

Study Site

Other Identifiers

2121166

Identifier Type: -

Identifier Source: org_study_id