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Trial record 45 of 68 for:    tpn

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

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

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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




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



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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216799


Locations
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Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 11211
Sponsors and Collaborators
King Faisal Specialist Hospital & Research Center
Investigators
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Principal Investigator: Hakeam A Hakeam, MS., BCPS King Faisal Specialist Hospital & Research Centre

Additional Information:
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Responsible Party: King Faisal Specialist Hospital & Research Center
ClinicalTrials.gov Identifier: NCT02216799     History of Changes
Other Study ID Numbers: 2121166
First Posted: August 15, 2014    Key Record Dates
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:
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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