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Insulin Infusion Diabetes Ulcer (IINDU)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT00700154
First received: June 9, 2008
Last updated: December 6, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Plasma glucose levels [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: December 2013 (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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700154

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

Publications:

Responsible Party: Mats Bonnier, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00700154     History of Changes
Other Study ID Numbers: IICVS_00
Study First Received: June 9, 2008
Last Updated: December 6, 2011
Health Authority: Sweden: Institutional Review Board

Keywords provided by Karolinska Institutet:
Vascular Surgery
Complications
Hyperglycemia
 Insulin infusion
Diabetic ulcers
Infection

Additional relevant MeSH terms:
Diabetes Mellitus
Hyperglycemia
Insulin Resistance
Ulcer
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Pathologic Processes
Insulin aspart
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013