drugset / Trial / NCT03419767
Insulin Resistance in Patients After Carotid Revascularization
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The main purpose of this study is to study the phenomenon of insulin resistance in patients after carotid revascularization surgery through population-based, randomized, double-blind, placebo-controlled trial.
Timeline
- Start
- 2017-08-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
Publications
- Background Jovanovski-Srceva M, Kuzmanovska B, Mojsova M, Kartalov A, Shosholcheva M, Temelkovska-Stevanoska M, Gavrilovska A, Stavridis S, Spirovski Z, Kondov B, Kokareva A, Todorov R, Spirovska T. Insulin Resistance, Glycemia and Cortisol Levels in Surgical Patients who Had Preoperative Caloric Load with Amino Acids. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):61-70. doi: 10.1515/prilozi-2015-0079.
- Background de Luis D, Izaola O, de la Fuente B, Aller R. Effect of L-arginine supplementation on insulin resistance and adipocitokines levels in head and neck cancer non diabetic patients after surgery. Nutr Hosp. 2014 Oct 10;30(4):870-5. doi: 10.3305/nh.2014.30.4.7864.
- Background van Stijn MFM, Soeters MR, van Leeuwen PAM, Schreurs WH, Schoorl MG, Twisk JWR, De Bandt JP, Bonnefont-Rousselot D, Cynober L, Ackermans MT, Serlie MJ, Houdijk APJ. Effects of a Carbohydrate-, Glutamine-, and Antioxidant-Enriched Oral Nutrition Supplement on Major Surgery-Induced Insulin Resistance: A Randomized Pilot Study. JPEN J Parenter Enteral Nutr. 2018 May;42(4):719-729. doi: 10.1177/0148607117711691. Epub 2017 Dec 20.
- Background Singh M, Chaudhary M, Vashistha A, Kaur G. Evaluation of effects of a preoperative 2-hour fast with glutamine and carbohydrate rich drink on insulin resistance in maxillofacial surgery. J Oral Biol Craniofac Res. 2015 Jan-Apr;5(1):34-9. doi: 10.1016/j.jobcr.2015.02.006. Epub 2015 Mar 4.
- Background Thorell A, Nygren J, Ljungqvist O. Insulin resistance: a marker of surgical stress. Curr Opin Clin Nutr Metab Care. 1999 Jan;2(1):69-78. doi: 10.1097/00075197-199901000-00012.
- Background Ljungqvist O. Jonathan E. Rhoads lecture 2011: Insulin resistance and enhanced recovery after surgery. JPEN J Parenter Enteral Nutr. 2012 Jul;36(4):389-98. doi: 10.1177/0148607112445580. Epub 2012 May 10.
- Background Zareba K, Kamocki Z, Kuklinski A, Kedra B. Problem of the insulin resistance in surgery. Pol Przegl Chir. 2011 May;83(5):287-91. doi: 10.2478/v10035-011-0045-1. No abstract available.
- Background Wang ZG, Wang Q, Wang WJ, Qin HL. Randomized clinical trial to compare the effects of preoperative oral carbohydrate versus placebo on insulin resistance after colorectal surgery. Br J Surg. 2010 Mar;97(3):317-27. doi: 10.1002/bjs.6963.
- Background Kucukakin B, Gogenur I, Reiter RJ, Rosenberg J. Oxidative stress in relation to surgery: is there a role for the antioxidant melatonin? J Surg Res. 2009 Apr;152(2):338-47. doi: 10.1016/j.jss.2007.12.753. Epub 2008 Jan 10.
- Background Kucukakin B, Lykkesfeldt J, Nielsen HJ, Reiter RJ, Rosenberg J, Gogenur I. Utility of melatonin to treat surgical stress after major vascular surgery--a safety study. J Pineal Res. 2008 May;44(4):426-31. doi: 10.1111/j.1600-079X.2007.00545.x. Epub 2008 Jan 15.
- Background Tangvarasittichai S. Oxidative stress, insulin resistance, dyslipidemia and type 2 diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):456-80. doi: 10.4239/wjd.v6.i3.456.
- Background Keane KN, Cruzat VF, Carlessi R, de Bittencourt PI Jr, Newsholme P. Molecular Events Linking Oxidative Stress and Inflammation to Insulin Resistance and beta-Cell Dysfunction. Oxid Med Cell Longev. 2015;2015:181643. doi: 10.1155/2015/181643. Epub 2015 Jul 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 6 mg | Oral |