Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Insulin Infusion Diabetes Ulcer (IINDU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00700154
Recruitment Status : Terminated (participants are no longer being examined or receiving intervention)
First Posted : June 18, 2008
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Mats Bonnier, Karolinska Institutet

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual 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.
Actual Study Start Date : November 2011
Actual Primary Completion Date : December 21, 2020
Actual Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Sweden
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, Sweden, SE-171 76
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Study Director: Kerstin Brismar, Professor Karolinska Institutet
Principal Investigator: Mats Bonnier, M.D Karolinska Institutet
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Mats Bonnier, MD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT00700154    
Other Study ID Numbers: IICVS_00
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Keywords provided by Mats Bonnier, Karolinska Institutet:
Vascular Surgery
Complications
Hyperglycemia
 Insulin infusion
Diabetic ulcers
Infection
Additional relevant MeSH terms:
Layout table for MeSH terms
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