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Insulin Infusion Diabetes Ulcer (IINDU)

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet Identifier:
First received: June 9, 2008
Last updated: April 8, 2015
Last verified: December 2011

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 Intervention Phase
Diabetes Mellitus Insulin Resistance Hyperglycemia Surgery Ulcers Infection Procedure: Insulin infusion Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Mats Bonnier, Karolinska Institutet:

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

Secondary Outcome Measures:
  • Hospital stay [ Time Frame: 4 weeks ]
  • HbA1c [ Time Frame: 4 weeks ]
  • laboratories for inflammation and oxidative stress [ Time Frame: 4 weeks ]

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00700154

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


Responsible Party: Mats Bonnier, MD, Karolinska Institutet Identifier: NCT00700154     History of Changes
Other Study ID Numbers: IICVS_00
Study First Received: June 9, 2008
Last Updated: April 8, 2015

Keywords provided by Mats Bonnier, Karolinska Institutet:
Vascular Surgery
Insulin infusion
Diabetic ulcers

Additional relevant MeSH terms:
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Insulin, Globin Zinc
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017