Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Total Parenteral Nutrition
Information source: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition
Intervention: Glargine Insulin (Drug); Regular insulin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: King Faisal Specialist Hospital & Research Center Official(s) and/or principal investigator(s): Hakeam A Hakeam, MS., BCPS, Principal Investigator, Affiliation: King Faisal Specialist Hospital & Research Centre
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.
Clinical Details
Official title: Glargine Insulin Versus Continous Regular Insulin in Diabetic Surgical Patients Receiving Total Parenteral Nutrition
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Achievement of target blood glucose (140 mg/dL to 200 mg/dL)
Secondary outcome: Developement of hypoglycemia ( blood glucose < 70 mg/dL)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
King Faisal Specialist Hospital & Research Centre, Riyadh 11211, Saudi Arabia; Recruiting Abir H Omer, MD, Phone: +966 11 442 3657, Email: aomer@kfshrc.edu.sa Hakeam A Hakeam, MS., BCPS, Principal Investigator
Additional Information
Study Site
Starting date: March 2013
Last updated: April 6, 2015
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