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

NCT02216799 | Completed Phase 4

• 1 other identifier: 2121166
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

Parenteral nutrition; Hyperglycemia; Glargine insulin; Regular insulin

Outcome Measures

Primary Outcomes (1)

• Achievement of target blood glucose (140 mg/dL to 200 mg/dL)

  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

  2-years

Secondary Outcomes (1)

• Developement of hypoglycemia ( blood glucose < 70 mg/dL)

  2-years

Study Arms (2)

Regular Insulin incorporated in parenteral nutrition

ACTIVE COMPARATOR

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; Drug: Regular insulin

Insulin glargine

ACTIVE COMPARATOR

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; Drug: Regular insulin

Interventions

Glargine Insulin DRUG

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

Also known as: LANTUS (insulin glargine [rDNA origin] injection

Insulin glargine; Regular Insulin incorporated in parenteral nutrition

Regular insulin DRUG

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

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

Insulin glargine; Regular Insulin incorporated in parenteral nutrition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Centre

Riyadh, Riyadh Region, 11211, Saudi Arabia

Location

Related Links

• Study Site

MeSH Terms

Conditions

Hyperphagia; Hyperglycemia; Insulin Resistance

Interventions

Insulin Glargine; Injections; Insulin; DNA, Ribosomal

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Drug Administration Routes; Drug Therapy; Therapeutics; Proinsulin; DNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hakeam A Hakeam, MS., BCPS

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: March 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 25, 2016

Record last verified: 2015-04

Locations

SA (1)