Insulin Infusion Diabetes Ulcer (IINDU)
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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
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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 |

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 |

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.
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- Plasma glucose levels [ Time Frame: 4 weeks ]
- Hospital stay [ Time Frame: 4 weeks ]
- HbA1c [ Time Frame: 4 weeks ]
- laboratories for inflammation and oxidative stress [ Time Frame: 4 weeks ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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:
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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

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
Sweden | |
Department of Vascular Surgery, Karolinska University Hospital | |
Stockholm, Sweden, SE-171 76 |
Study Director: | Kerstin Brismar, Professor | Karolinska Institutet | |
Principal Investigator: | Mats Bonnier, M.D | Karolinska Institutet |
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 |
Vascular Surgery Complications Hyperglycemia |
Insulin infusion Diabetic ulcers Infection |
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 |