Evaluate the Possible Efficacy and Safety of Empagliflozin in Patient With Ulcerative Colitis

Summary

•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.

Timeline

Start

2023-01-01

Primary completion

2025-12-01

Completion

2026-12-01

Publications

• Background Karle EJ, Gehring F, Trautner K. [Cariogenic properties of various snacks in animal experiments]. Dtsch Zahnarztl Z. 1977 Sep;32(9):741-3. German.
• Background Rubin DT, Huo D, Kinnucan JA, Sedrak MS, McCullom NE, Bunnag AP, Raun-Royer EP, Cohen RD, Hanauer SB, Hart J, Turner JR. Inflammation is an independent risk factor for colonic neoplasia in patients with ulcerative colitis: a case-control study. Clin Gastroenterol Hepatol. 2013 Dec;11(12):1601-8.e1-4. doi: 10.1016/j.cgh.2013.06.023. Epub 2013 Jul 17.
• Background Gasche C, Scholmerich J, Brynskov J, D'Haens G, Hanauer SB, Irvine EJ, Jewell DP, Rachmilewitz D, Sachar DB, Sandborn WJ, Sutherland LR. A simple classification of Crohn's disease: report of the Working Party for the World Congresses of Gastroenterology, Vienna 1998. Inflamm Bowel Dis. 2000 Feb;6(1):8-15. doi: 10.1097/00054725-200002000-00002.
• Background Colman RJ, Rubin DT. Histological inflammation increases the risk of colorectal neoplasia in ulcerative colitis: a systematic review. Intest Res. 2016 Jul;14(3):202-10. doi: 10.5217/ir.2016.14.3.202. Epub 2016 Jun 27.
• Background Esmat S, El Nady M, Elfekki M, Elsherif Y, Naga M. Epidemiological and clinical characteristics of inflammatory bowel diseases in Cairo, Egypt. World J Gastroenterol. 2014 Jan 21;20(3):814-21. doi: 10.3748/wjg.v20.i3.814.
• Background Jess T, Frisch M, Simonsen J. Trends in overall and cause-specific mortality among patients with inflammatory bowel disease from 1982 to 2010. Clin Gastroenterol Hepatol. 2013 Jan;11(1):43-8. doi: 10.1016/j.cgh.2012.09.026. Epub 2012 Sep 27.
• Background Regueiro M, Greer JB, Szigethy E. Etiology and Treatment of Pain and Psychosocial Issues in Patients With Inflammatory Bowel Diseases. Gastroenterology. 2017 Feb;152(2):430-439.e4. doi: 10.1053/j.gastro.2016.10.036. Epub 2016 Nov 2.
• Background MacDermott RP, Sanderson IR, Reinecker HC. The central role of chemokines (chemotactic cytokines) in the immunopathogenesis of ulcerative colitis and Crohn's disease. Inflamm Bowel Dis. 1998 Feb;4(1):54-67. doi: 10.1097/00054725-199802000-00009.
• Background Greenstein AJ, Sachar DB, Gibas A, Schrag D, Heimann T, Janowitz HD, Aufses AH Jr. Outcome of toxic dilatation in ulcerative and Crohn's colitis. J Clin Gastroenterol. 1985 Apr;7(2):137-43. doi: 10.1097/00004836-198504000-00007.
• Background Jalan KN, Sircus W, Card WI, Falconer CW, Bruce CB, Crean GP, McManus JP, Small WP, Smith AN. An experience of ulcerative colitis. I. Toxic dilation in 55 cases. Gastroenterology. 1969 Jul;57(1):68-82. No abstract available.
• Background Bedine MS. Textbook of gastroenterology. Gastroenterology. 2000 May;118(5):984-5. doi: 10.1016/s0016-5085(00)70191-0. No abstract available.
• Background Bernstein CN, Wajda A, Blanchard JF. The incidence of arterial thromboembolic diseases in inflammatory bowel disease: a population-based study. Clin Gastroenterol Hepatol. 2008 Jan;6(1):41-5. doi: 10.1016/j.cgh.2007.09.016. Epub 2007 Dec 11.
• Background Merigo F, Brandolese A, Facchin S, Missaggia S, Bernardi P, Boschi F, D'Inca R, Savarino EV, Sbarbati A, Sturniolo GC. Glucose transporter expression in the human colon. World J Gastroenterol. 2018 Feb 21;24(7):775-793. doi: 10.3748/wjg.v24.i7.775.
• Background Zhou H, Wang S, Zhu P, Hu S, Chen Y, Ren J. Empagliflozin rescues diabetic myocardial microvascular injury via AMPK-mediated inhibition of mitochondrial fission. Redox Biol. 2018 May;15:335-346. doi: 10.1016/j.redox.2017.12.019. Epub 2017 Dec 30.
• Background Iannantuoni F, M de Maranon A, Diaz-Morales N, Falcon R, Banuls C, Abad-Jimenez Z, Victor VM, Hernandez-Mijares A, Rovira-Llopis S. The SGLT2 Inhibitor Empagliflozin Ameliorates the Inflammatory Profile in Type 2 Diabetic Patients and Promotes an Antioxidant Response in Leukocytes. J Clin Med. 2019 Nov 1;8(11):1814. doi: 10.3390/jcm8111814.

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Indications