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

NCT02216799 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-02-25

No results posted yet for this study

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

Interventions

DRUG

Glargine Insulin

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

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

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Hakeam A Hakeam, MS., BCPS · King Faisal Specialist Hospital & Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02216799 on ClinicalTrials.gov