MedTrace Logo

Insulin Infusion Diabetes Ulcer

NCT00700154 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-12-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kerstin Brismar, Professor · Karolinska Institutet

  • Mats Bonnier, M.D · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2020-12-21
Completion
2020-12-21

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00700154 on ClinicalTrials.gov