Insulin Infusion and Infectious Diabetic Foot Ulcers (IIIFU)

NCT00700362 | Withdrawn DMC

• 1 other identifier: IIIFU_00
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 foot ulcer infection and surgical wound infection.

• The study evaluates a target controlled insulin infusion or conventional therapy as antidiabetic treatment during foot ulcer infection and surgical wound infection.
• Secondary efficacy parameter will be hospital stay, laboratories for inflammation and oxidative stress.

Conditions

Diabetes Mellitus; Insulin Resistance; Hyperglycemia; Infection

Keywords

Complications; Hyperglycemia; Insulin infusion

Outcome Measures

Primary Outcomes (1)

• Plasma glucose level.

  4 weeks

Secondary Outcomes (3)

• Hospital stay

  4 weeks

• HbA1c

  4 weeks

• laboratories for inflammation and oxidative stress.

  4 weeks

Interventions

Insulin infusion (aspart) PROCEDURE

The insulin infusion, a fast acting insulin analog (aspart) in 1 Unit/ml of NaCl, starts when the patients full fill the eligibility criteria and has signed the informed consent. 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.

Standard care PROCEDURE

Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Office patients

You may qualify if:

• Postoperative or infectious patients with: skin-, airways-, urine tract- or gastro-intestinal infections.
• Hyperglycaemia: Capillary P-glucose above 8 mmol/L.
• Older than 18 years.
• Informed consent obtained.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Department of Molecular Medicine and Surgery, Rolf Luft Research Center for Diabetes and Endocrinology

Stockholm, 171 76, Sweden

Location

Related Publications (20)

• Bonnier M, Lonnroth P, Gudbjornsdottir S, Attvall S, Jansson PA. Validation of a glucose-insulin-potassium infusion algorithm in hospitalized diabetic patients. J Intern Med. 2003 Feb;253(2):189-93. doi: 10.1046/j.1365-2796.2003.01085.x.

  PMID: 12542559 BACKGROUND

• Van den Berghe G, Wilmer A, Milants I, Wouters PJ, Bouckaert B, Bruyninckx F, Bouillon R, Schetz M. Intensive insulin therapy in mixed medical/surgical intensive care units: benefit versus harm. Diabetes. 2006 Nov;55(11):3151-9. doi: 10.2337/db06-0855.

  PMID: 17065355 BACKGROUND

• Sjoholm A, Nystrom T. Endothelial inflammation in insulin resistance. Lancet. 2005 Feb 12-18;365(9459):610-2. doi: 10.1016/S0140-6736(05)17912-4.

  PMID: 15708106 BACKGROUND

• Bastard JP, Maachi M, Lagathu C, Kim MJ, Caron M, Vidal H, Capeau J, Feve B. Recent advances in the relationship between obesity, inflammation, and insulin resistance. Eur Cytokine Netw. 2006 Mar;17(1):4-12.

  PMID: 16613757 BACKGROUND

• Sjoholm A, Nystrom T. Inflammation and the etiology of type 2 diabetes. Diabetes Metab Res Rev. 2006 Jan-Feb;22(1):4-10. doi: 10.1002/dmrr.568.

  PMID: 15991254 BACKGROUND

• Brismar K, Fernqvist-Forbes E, Wahren J, Hall K. Effect of insulin on the hepatic production of insulin-like growth factor-binding protein-1 (IGFBP-1), IGFBP-3, and IGF-I in insulin-dependent diabetes. J Clin Endocrinol Metab. 1994 Sep;79(3):872-8. doi: 10.1210/jcem.79.3.7521354.

  PMID: 7521354 BACKGROUND

• Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.

  PMID: 18200806 BACKGROUND

• Abourizk NN, Vora CK, Verma PK. Inpatient diabetology. The new frontier. J Gen Intern Med. 2004 May;19(5 Pt 1):466-71. doi: 10.1111/j.1525-1497.2004.30133.x.

  PMID: 15109346 BACKGROUND

• Subramaniam B, Panzica PJ, Novack V, Mahmood F, Matyal R, Mitchell JD, Sundar E, Bose R, Pomposelli F, Kersten JR, Talmor DS. Continuous perioperative insulin infusion decreases major cardiovascular events in patients undergoing vascular surgery: a prospective, randomized trial. Anesthesiology. 2009 May;110(5):970-7. doi: 10.1097/ALN.0b013e3181a1005b.

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  PMID: 18203960 BACKGROUND

• Griesdale DE, de Souza RJ, van Dam RM, Heyland DK, Cook DJ, Malhotra A, Dhaliwal R, Henderson WR, Chittock DR, Finfer S, Talmor D. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data. CMAJ. 2009 Apr 14;180(8):821-7. doi: 10.1503/cmaj.090206. Epub 2009 Mar 24.

  PMID: 19318387 BACKGROUND

• Campbell RK. Etiology and effect on outcomes of hyperglycemia in hospitalized patients. Am J Health Syst Pharm. 2007 May 15;64(10 Suppl 6):S4-8. doi: 10.2146/ajhp070100.

  PMID: 17494892 BACKGROUND

• Van den Berghe G, Schetz M, Vlasselaers D, Hermans G, Wilmer A, Bouillon R, Mesotten D. Clinical review: Intensive insulin therapy in critically ill patients: NICE-SUGAR or Leuven blood glucose target? J Clin Endocrinol Metab. 2009 Sep;94(9):3163-70. doi: 10.1210/jc.2009-0663. Epub 2009 Jun 16.

  PMID: 19531590 BACKGROUND

• Kotronen A, Lewitt M, Hall K, Brismar K, Yki-Jarvinen H. Insulin-like growth factor binding protein 1 as a novel specific marker of hepatic insulin sensitivity. J Clin Endocrinol Metab. 2008 Dec;93(12):4867-72. doi: 10.1210/jc.2008-1245. Epub 2008 Sep 16.

  PMID: 18796514 BACKGROUND

• King GL. The role of inflammatory cytokines in diabetes and its complications. J Periodontol. 2008 Aug;79(8 Suppl):1527-34. doi: 10.1902/jop.2008.080246.

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MeSH Terms

Conditions

Diabetes Mellitus; Insulin Resistance; Hyperglycemia; Infections

Interventions

Insulin Aspart; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Kerstin Brismar, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2008
• First Posted: June 18, 2008
• Study Start: December 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

SE (1)