drugset / Trial / NCT03341117
Acetylsalicylic Acid and Type 2 Diabetes Mellitus
RandomizedSingle-groupDouble-blindTreatment
Summary
OBJETIVE To assess the effect of acetylsalicylic acid on antioxidant enzymatic system in patients with type 2 diabetes
Timeline
- Start
- 2014-12-02
- Primary completion
- 2015-12-02
- Completion
- 2016-12-02
Publications
- Background Jandeleit-Dahm K, Cooper ME. The role of AGEs in cardiovascular disease. Curr Pharm Des. 2008;14(10):979-86. doi: 10.2174/138161208784139684.
- Background Rahimi R, Nikfar S, Larijani B, Abdollahi M. A review on the role of antioxidants in the management of diabetes and its complications. Biomed Pharmacother. 2005 Aug;59(7):365-73. doi: 10.1016/j.biopha.2005.07.002.
- Background Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.
- Background Henriksen EJ, Diamond-Stanic MK, Marchionne EM. Oxidative stress and the etiology of insulin resistance and type 2 diabetes. Free Radic Biol Med. 2011 Sep 1;51(5):993-9. doi: 10.1016/j.freeradbiomed.2010.12.005. Epub 2010 Dec 13.
- Background Johansen JS, Harris AK, Rychly DJ, Ergul A. Oxidative stress and the use of antioxidants in diabetes: linking basic science to clinical practice. Cardiovasc Diabetol. 2005 Apr 29;4:5. doi: 10.1186/1475-2840-4-5.
- Background Zatalia SR, Sanusi H. The role of antioxidants in the pathophysiology, complications, and management of diabetes mellitus. Acta Med Indones. 2013 Apr;45(2):141-7.
- Background Newsholme P, Haber EP, Hirabara SM, Rebelato EL, Procopio J, Morgan D, Oliveira-Emilio HC, Carpinelli AR, Curi R. Diabetes associated cell stress and dysfunction: role of mitochondrial and non-mitochondrial ROS production and activity. J Physiol. 2007 Aug 15;583(Pt 1):9-24. doi: 10.1113/jphysiol.2007.135871. Epub 2007 Jun 21.
- Background Lapshina EA, Sudnikovich EJ, Maksimchik JZ, Zabrodskaya SV, Zavodnik LB, Kubyshin VL, Nocun M, Kazmierczak P, Dobaczewski M, Watala C, Zavodnik IB. Antioxidative enzyme and glutathione S-transferase activities in diabetic rats exposed to long-term ASA treatment. Life Sci. 2006 Oct 4;79(19):1804-11. doi: 10.1016/j.lfs.2006.06.008. Epub 2006 Jun 15.
- Background Baltazar MT, Dinis-Oliveira RJ, Duarte JA, Bastos ML, Carvalho F. Antioxidant properties and associated mechanisms of salicylates. Curr Med Chem. 2011;18(21):3252-64. doi: 10.2174/092986711796391552.
- Background Caballero F, Gerez E, Batlle A, Vazquez E. Preventive aspirin treatment of streptozotocin induced diabetes: blockage of oxidative status and revertion of heme enzymes inhibition. Chem Biol Interact. 2000 Jun 1;126(3):215-25. doi: 10.1016/s0009-2797(00)00168-x.
- Background Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21.
- Background Goldfine AB, Silver R, Aldhahi W, Cai D, Tatro E, Lee J, Shoelson SE. Use of salsalate to target inflammation in the treatment of insulin resistance and type 2 diabetes. Clin Transl Sci. 2008 May;1(1):36-43. doi: 10.1111/j.1752-8062.2008.00026.x.
- Background Blakytny R, Harding JJ. Prevention of cataract in diabetic rats by aspirin, paracetamol (acetaminophen) and ibuprofen. Exp Eye Res. 1992 Apr;54(4):509-18. doi: 10.1016/0014-4835(92)90129-g.
- Background Coudray C, Favier A. Determination of salicylate hydroxylation products as an in vivo oxidative stress marker. Free Radic Biol Med. 2000 Dec;29(11):1064-70. doi: 10.1016/s0891-5849(00)00403-2.
- Background Ames PR, Batuca JR, Muncy IJ, De La Torre IG, Pascoe-Gonzales S, Guyer K, Matsuura E, Lopez LR. Aspirin insensitive thromboxane generation is associated with oxidative stress in type 2 diabetes mellitus. Thromb Res. 2012 Sep;130(3):350-4. doi: 10.1016/j.thromres.2012.03.025. Epub 2012 Apr 20.
- Background Lemkes BA, Bahler L, Kamphuisen PW, Stroobants AK, Van Den Dool EJ, Hoekstra JB, Nieuwland R, Gerdes VE, Holleman F. The influence of aspirin dose and glycemic control on platelet inhibition in patients with type 2 diabetes mellitus. J Thromb Haemost. 2012 Apr;10(4):639-46. doi: 10.1111/j.1538-7836.2012.04632.x.
- Background Muller KA, Chatterjee M, Rath D, Geisler T. Platelets, inflammation and anti-inflammatory effects of antiplatelet drugs in ACS and CAD. Thromb Haemost. 2015 Aug 31;114(3):498-518. doi: 10.1160/TH14-11-0947. Epub 2015 Jul 30.
- Background Nagelschmitz J, Blunck M, Kraetzschmar J, Ludwig M, Wensing G, Hohlfeld T. Pharmacokinetics and pharmacodynamics of acetylsalicylic acid after intravenous and oral administration to healthy volunteers. Clin Pharmacol. 2014 Mar 19;6:51-9. doi: 10.2147/CPAA.S47895. eCollection 2014.
- Background Dzeshka MS, Shantsila A, Lip GY. Effects of Aspirin on Endothelial Function and Hypertension. Curr Hypertens Rep. 2016 Nov;18(11):83. doi: 10.1007/s11906-016-0688-8.
- Background Grimaldi R, Bisi M, Lonni E, Beggiato E, Valpreda A, Lococo MF, Dosio E, Presutti DG, Tagliabue M, Gaita F. Laboratory aspirin resistance reversibility in diabetic patients: a pilot study using different pharmaceutical formulations. Cardiovasc Drugs Ther. 2014 Aug;28(4):323-9. doi: 10.1007/s10557-014-6536-7.
- Background Abdin AA, Baalash AA, Hamooda HE. Effects of rosiglitazone and aspirin on experimental model of induced type 2 diabetes in rats: focus on insulin resistance and inflammatory markers. J Diabetes Complications. 2010 May-Jun;24(3):168-78. doi: 10.1016/j.jdiacomp.2009.01.005. Epub 2009 Mar 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 300 mg | Oral |