Acetylsalicylic Acid and Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Acetylsalicylic Acid Administered in Patients With Type 2 Diabetes Mellitus and Its Effect on the Antioxidant Enzyme System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341117
• Other study ID #: 2345
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2017
• Last updated: November 8, 2017
• Start date: December 2, 2014
• Est. completion date: December 2, 2016

Study information

• Verified date: November 2017
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OBJETIVE To assess the effect of acetylsalicylic acid on antioxidant enzymatic system in patients with type 2 diabetes

Description:

A randomized, double blind placebo controlled clinical trial was carried out in 21 adult patients with type 2 diabetes. Acetylsalicylic acid 300mg/d was administered orally for 3 months to study group (n=11) and placebo to the control group (n=10).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2, 2016
• Est. primary completion date: December 2, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes

• BMI 25.0 - 35.0 kg/m2

• HbA1c between 6.5 - 9%.

• Written informed consent

• Same residential area and socioeconomic status.

Exclusion Criteria:

• Sedentary or heavy physical activity.

• Nonsmokers.

• Body weight was stable for al last 3 months before the study.

• Personal history of hepatic, renal, gastric or coronary artery disease.

• Hypersensibility to acetylsalicylic acid.

Related Conditions & MeSH terms

• Antioxidant Enzyme System
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Acetylsalicylic acid
Acetylsalicylic acid 300 mg per capsule
• Calcined magnesia
Calcined magnesia 300 mg per capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario de Ciencias de la Salud, Mexico

References & Publications (21)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Dzeshka MS, Shantsila A, Lip GY. Effects of Aspirin on Endothelial Function and Hypertension. Curr Hypertens Rep. 2016 Nov;18(11):83. Review. — View Citation

Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Jandeleit-Dahm K, Cooper ME. The role of AGEs in cardiovascular disease. Curr Pharm Des. 2008;14(10):979-86. Review. — View Citation

Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21. — View Citation

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. Review. — View Citation

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. Epub 2006 Jun 15. — View Citation

Lemkes BA, Bähler 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. — View Citation

Müller 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. Review. — View Citation

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. — View Citation

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. Epub 2007 Jun 21. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modification in the antioxidant enzymatic system activity (total antioxidant capacity, catalase, glutathione peroxidase , superoxide dismutase) in patients with type 2 diabetes after the administration of acetylsalicylic acid	In both groups (intervention an d placebo) of 21 patients each, all the patients with type 2 diabetes mellitus, the antioxidant enzymatic system activity was measured before and after the administration of the acetylsalicylic acid, one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.	90 days
Secondary	Modification in lipid profile in patients with type 2 diabetes after the administration of Acetylsalicylic Acid	In both groups (intervention and placebo ) of 21 patients each , all patients with type 2 diabetes mellitus, lipid profile was measured in mg/dL, before and after the administration of the acetylsalicylic acid, one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.	90 days
Secondary	Hepatic safety after the administration of acetylsalicylic acid through the determination of hepatic profile	The hepatic profile was determined through the serum levels of transaminases in U/L (Glutamic oxalacetic transaminase and Glutamic pyruvic transaminase) after of administration during 90 days of acetylsalicylic acid, The patient was on a 12-hour fast.	90 days
Secondary	Renal safety of administration of acetylsalicylic acid through the determination of serum creatinine	The serum creatinine was measured in mg/dL, before and after of administration during 90 days of acetylsalicylic acid. The patient was on a 12-hour fast.	90 days
Secondary	Modification in HbA1c in patients with type 2 diabetes after the administration of Acetylsalicylic Acid	In both groups (intervention and placebo ) of 21 patients each , all patients with type 2 diabetes mellitus, HbA1c was measured in %, before and after the administration of the acetylsalicylic acid, one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.	90 days
Secondary	Modification in fasting glucose in patients with type 2 diabetes after the administration of Acetylsalicylic acid	In both groups (intervention and placebo ) of 21 patients each , all patients with type 2 diabetes mellitus, glucose was measured in mg/dL, before and after the administration of the acetylsalicylic acid, one capsule before each food for a period of 90 days. The patient was on a 12-hour fast.	90 days