Insulin Infusion Diabetes Ulcer (IINDU)
|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
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00700154
|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|