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Insulin Infusion Diabetes Ulcer (IINDU)

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ClinicalTrials.gov Identifier: NCT00700154
Recruitment Status : Unknown
Verified December 2011 by Mats Bonnier, Karolinska Institutet.
Recruitment status was:  Enrolling by invitation
First Posted : June 18, 2008
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet

Study Description
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Brief Summary:

Normoglycemia is important for the outcome of surgical and medical conditions. Insulin infusions have been studied to achieve normoglycemia during these circumstances and have proved to be useful. Insulin given by subcutaneous injections has longer duration compared to intravenous given insulin which makes it more difficult to control. The hypothesis behind the trial is the concept that insulin infusion is more effective in reaching normoglycemia in diabetic subjects during treatment for ulcer infections and/or planned cardio-vascular surgery.

  • The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during ulcer infection and after cardio- vascular surgery.
  • Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Insulin Resistance Hyperglycemia Surgery Ulcers Infection Procedure: Insulin infusion Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Insulin Infusion on Metabolic Control and Inflammation in Diabetic Patients During Cardio-vascular Intervention and/or Treatment for Acute Foot Ulcer Infection.
Study Start Date : November 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : November 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin infusion (aspart) Procedure: Insulin infusion
The infusion, a fast acting insulin analog in 1 Unit/ml of NaCl, starts prior the surgery the operation day for all patients and stops during the postoperative care in the control group (conventional therapy), the intervention group continues for three full days with insulin infusion. After the transition day (the fourth day) multiple doses of mixinsulin continues until the study ends 4 weeks after the randomization.
Other Name: Insulin aspart: NovoRapid
No Intervention: Standard care
Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.


Outcome Measures
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Primary Outcome Measures :
  1. Plasma glucose levels [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Hospital stay [ Time Frame: 4 weeks ]
  2. HbA1c [ Time Frame: 4 weeks ]
  3. laboratories for inflammation and oxidative stress [ Time Frame: 4 weeks ]

Eligibility Criteria
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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:

  • Patients are eligible for inclusion if the following criteria are fulfilled:

    • Patients with diabetes type 1 or type 2.
    • Older than 18 years.
    • Patients scheduled for cardio- vascular surgery and/ or acute ulcer infection.
    • Hyperglycaemia: Capillary P-glucose above 8 mmol/L.
    • Informed consent obtained.

Exclusion Criteria:

  • Patients having any of the following at randomization will not be included in the study:

    • Unconsciousness: not possible to wake up.
    • Ketoacidosis: pH less or equal to 7.30.
    • Hyperosmolar syndrome: S-Na more or equal to 150 mmol/L.
    • Kidney failure: calculated GFR < 30 mL/min.
    • Pregnancy.
    • Mental condition making the subject unable to understand the concepts and risk of the study
Contacts and Locations
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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): NCT00700154


Locations
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Sweden
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Director: Kerstin Brismar, Professor Karolinska Institutet
Principal Investigator: Mats Bonnier, M.D Karolinska Institutet
More Information
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Publications:

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Responsible Party: Mats Bonnier, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00700154     History of Changes
Other Study ID Numbers: IICVS_00
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: December 2011
Keywords provided by Mats Bonnier, Karolinska Institutet:
Vascular Surgery
Complications
Hyperglycemia
 Insulin infusion
Diabetic ulcers
Infection
Additional relevant MeSH terms:
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Infection
Insulin Resistance
Hyperglycemia
Ulcer
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
 Metabolic Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs