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

• ClinicalTrials.gov Identifier: NCT02216799
• Recruitment Status: Completed
• First Posted: August 15, 2014
• Last Update Posted: February 25, 2016
• Sponsor: King Faisal Specialist Hospital & Research Center
• Information provided by (Responsible Party): King Faisal Specialist Hospital & Research Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition	Drug: Glargine Insulin; Drug: Regular insulin	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)
• Study Start Date: March 2013
• Actual Primary Completion Date: August 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk

Outcome Measures

Primary Outcome Measures :

1. Achievement of target blood glucose (140 mg/dL to 200 mg/dL) [ Time Frame: 2-years ]

   Assessemnt of:

   1. Whole blood glucose every morning
   2. 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

Secondary Outcome Measures :

1. Developement of hypoglycemia ( blood glucose < 70 mg/dL) [ Time Frame: 2-years ]
   To assess the development of hypoglycemia in both arms of the study

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Saudi Arabia

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia, 11211

Sponsors and Collaborators

King Faisal Specialist Hospital & Research Center

Investigators

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

More Information

Additional Information:

Study Site 

• Responsible Party: King Faisal Specialist Hospital & Research Center
• ClinicalTrials.gov Identifier: NCT02216799
• Other Study ID Numbers: 2121166
• First Posted: August 15, 2014
• Last Update Posted: February 25, 2016
• Last Verified: April 2015

Keywords provided by King Faisal Specialist Hospital & Research Center:

Parenteral nutrition; Hyperglycemia; Glargine insulin; Regular insulin

Additional relevant MeSH terms:

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Insulin; Insulin, Globin Zinc; Insulin Glargine; Hypoglycemic Agents; Physiological Effects of Drugs