Local regulations
The Effect of Insulin-Glucose Infusion on Metabolic Control (Primary) and Inflammation (Secondary) in Diabetic Patients Treated for Acute Foot Ulcer Infection or Surgical Wound Infection
Sponsor study identifier
observational
0
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 16, 2008
Actual (reported)June 18, 2008
Actual (reported)December 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Plasma glucose level.
4 weeks
Hospital stay
4 weeks
HbA1c
4 weeks
laboratories for inflammation and oxidative stress.
4 weeks
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.
Glucose control according to standard care at the ward, i.e., sliding scale insulin at the discretion of responsible physician.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Office patients
Department of Molecular Medicine and Surgery, Rolf Luft Research Center for Diabetes and Endocrinology
Stockholm, 171 76, Sweden
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.
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.
Kerstin Brismar, Professor
Karolinska Institutet
0 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2008
First Posted
June 18, 2008
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
NPH and Regular Insulin in the Treatment of Inpatient Hyperglycemia: Comparison of 3 Basal-bolus Regimens
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Hadi HA, Suwaidi JA. Endothelial dysfunction in diabetes mellitus. Vasc Health Risk Manag. 2007;3(6):853-76.
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.
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.
Collier B, Dossett LA, May AK, Diaz JJ. Glucose control and the inflammatory response. Nutr Clin Pract. 2008 Feb;23(1):3-15. doi: 10.1177/011542650802300103.
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.
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.
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.
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.
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.
Pickup JC. Inflammation and activated innate immunity in the pathogenesis of type 2 diabetes. Diabetes Care. 2004 Mar;27(3):813-23. doi: 10.2337/diacare.27.3.813.
Haynes WG. Role of leptin in obesity-related hypertension. Exp Physiol. 2005 Sep;90(5):683-8. doi: 10.1113/expphysiol.2005.031237. Epub 2005 Aug 16.
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. doi: 10.1590/s0066-782x2010000200021. 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.
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.
Primary Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 5, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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