Insulin Infusion Diabetes Ulcer - Full Text View

Purpose

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	Intervention	Phase
Diabetes Mellitus Insulin Resistance Hyperglycemia Surgery Ulcers Infection	Procedure: Insulin infusion	Phase 4


Study Type:	Interventional
Study Design:	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.

Resource links provided by NLM:

Drug Information available for: Insulin Insulin human Insulin aspart

U.S. FDA Resources

Further study details as provided by Mats Bonnier, Karolinska Institutet:

Primary Outcome Measures:

Plasma glucose levels [ Time Frame: 4 weeks ]

Secondary Outcome Measures:

Hospital stay [ Time Frame: 4 weeks ]
HbA1c [ Time Frame: 4 weeks ]
laboratories for inflammation and oxidative stress [ Time Frame: 4 weeks ]


Estimated Enrollment:	40
Study Start Date:	November 2011
Estimated Study Completion Date:	November 2017
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700154

Locations


Sweden
Department of Vascular Surgery, Karolinska University Hospital
Stockholm, Sweden, SE-171 76

Sponsors and Collaborators

Karolinska Institutet

Investigators


Study Director:	Kerstin Brismar, Professor	Karolinska Institutet
Principal Investigator:	Mats Bonnier, M.D	Karolinska Institutet

More Information

Publications:

Malmstedt J, Wahlberg E, Jörneskog G, Swedenborg J. Influence of perioperative blood glucose levels on outcome after infrainguinal bypass surgery in patients with diabetes. Br J Surg. 2006 Nov;93(11):1360-7.

Bonnier M, Lönnroth P, Gudbjörnsdottir 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.

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.

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. Review.

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.

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

Abourizk NN, Vora CK, Verma PK. Inpatient diabetology. The new frontier. J Gen Intern Med. 2004 May;19(5 Pt 1):466-71. Review.

Collier B, Dossett LA, May AK, Diaz JJ. Glucose control and the inflammatory response. Nutr Clin Pract. 2008 Feb;23(1):3-15. Review.

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. Review.

Sjöholm A, Nyström T. Inflammation and the etiology of type 2 diabetes. Diabetes Metab Res Rev. 2006 Jan-Feb;22(1):4-10. Review.

Sjöholm A, Nyström T. Endothelial inflammation in insulin resistance. Lancet. 2005 Feb 12-18;365(9459):610-2. Review.

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. Review.

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. Review.

Kotronen A, Lewitt M, Hall K, Brismar K, Yki-Järvinen 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.

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. Review.

Pickup JC. Inflammation and activated innate immunity in the pathogenesis of type 2 diabetes. Diabetes Care. 2004 Mar;27(3):813-23. Review.

Haynes WG. Role of leptin in obesity-related hypertension. Exp Physiol. 2005 Sep;90(5):683-8. Epub 2005 Aug 16. Review.

Gomes F, Telo DF, Souza HP, Nicolau JC, Halpern A, Serrano CV Jr. [Obesity and coronary artery disease: role of vascular inflammation]. Arq Bras Cardiol. 2010 Feb;94(2):255-61, 273-9, 260-6. Review. English, Portuguese, Spanish.

Arai Y, Kojima T, Takayama M, Hirose N. The metabolic syndrome, IGF-1, and insulin action. Mol Cell Endocrinol. 2009 Feb 5;299(1):124-8. doi: 10.1016/j.mce.2008.07.002. Epub 2008 Jul 11. Review.

Galic S, Oakhill JS, Steinberg GR. Adipose tissue as an endocrine organ. Mol Cell Endocrinol. 2010 Mar 25;316(2):129-39. doi: 10.1016/j.mce.2009.08.018. Epub 2009 Aug 31. Review.

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.

Van den Berghe G. Endocrine evaluation of patients with critical illness. Endocrinol Metab Clin North Am. 2003 Jun;32(2):385-410. Review.

Scurlock C, Raikhelkar J, Mechanick JI. Critique of normoglycemia in intensive care evaluation: survival using glucose algorithm regulation (NICE-SUGAR)--a review of recent literature. Curr Opin Clin Nutr Metab Care. 2010 Mar;13(2):211-4. doi: 10.1097/MCO.0b013e32833571f4. Review.


Responsible Party:	Mats Bonnier, MD, Karolinska Institutet
ClinicalTrials.gov Identifier:	NCT00700154 History of Changes
Other Study ID Numbers:	IICVS_00
Study First Received:	June 9, 2008
Last Updated:	April 8, 2015

Keywords provided by Mats Bonnier, Karolinska Institutet:


Vascular Surgery Complications Hyperglycemia	Insulin infusion Diabetic ulcers Infection

Additional relevant MeSH terms:


Infection Diabetes Mellitus Ulcer Insulin Resistance Hyperglycemia Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases	Pathologic Processes Hyperinsulinism Insulin, Globin Zinc Insulin Insulin Aspart Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017

Insulin Infusion Diabetes Ulcer (IINDU)