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

Primary Purpose

Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition

Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Glargine Insulin
Regular insulin
Sponsored by
King Faisal Specialist Hospital & Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition focused on measuring Parenteral nutrition, Hyperglycemia, Glargine insulin, Regular insulin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Faisal Specialist Hospital & Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Regular Insulin incorporated in parenteral nutrition

Insulin glargine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Developement of hypoglycemia ( blood glucose < 70 mg/dL)
To assess the development of hypoglycemia in both arms of the study

Full Information

First Posted
August 13, 2014
Last Updated
February 24, 2016
Sponsor
King Faisal Specialist Hospital & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02216799
Brief Title
Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)
Acronym
GLUCOSE-in-PN
Official Title
Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition
Keywords
Parenteral nutrition, Hyperglycemia, Glargine insulin, Regular insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Insulin incorporated in parenteral nutrition
Arm Type
Active Comparator
Arm Description
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
Arm Title
Insulin glargine
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Glargine Insulin
Other Intervention Name(s)
LANTUS (insulin glargine [rDNA origin] injection
Intervention Description
80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine
Intervention Type
Drug
Intervention Name(s)
Regular insulin
Other Intervention Name(s)
Regular insulin ( Actrapid, 100 unit/mL0 Solution for injection, Insulin Human (rDNA), Novo Nordisk
Intervention Description
80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours
Primary Outcome Measure Information:
Title
Achievement of target blood glucose (140 mg/dL to 200 mg/dL)
Description
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
Time Frame
2-years
Secondary Outcome Measure Information:
Title
Developement of hypoglycemia ( blood glucose < 70 mg/dL)
Description
To assess the development of hypoglycemia in both arms of the study
Time Frame
2-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakeam A Hakeam, MS., BCPS
Organizational Affiliation
King Faisal Specialist Hospital & Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Faisal Specialist Hospital & Research Centre
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia

12. IPD Sharing Statement

Links:
URL
http://www.kfshrc.edu.sa
Description
Study Site

Learn more about this trial

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

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