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OBJETIVE To assess the effect of acetylsalicylic acid on antioxidant enzymatic system in patients with type 2 diabetes
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylsalicylic acid | Active Comparator | The patients were randomly assigned to received Acetylsalicylic acid 300 mg once daily for 90 days |
|
| calcined magnesia | Placebo Comparator | The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule 300 mg before each meal for a period of 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid | Drug | Acetylsalicylic acid 300 mg per capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18473849 | 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. | |
| 16081237 | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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A randomized double blind, placebo controlled clinical trial was carried out in 21 drug naïve adults (35-50 year of age) with DM2 with <5 years since diagnosis. They were overweight or obese (BMI 25.0 - 35.0 kg/m2), had glycosylated hemoglobin A1C (HbA1c) level between 6.5 - 9%. This protocol study was reviewed and approved by the hospital based ethics committee, and written informed consent was obtained from all volunteers. Subject was selected from the same residential area and socioeconomic status. No participants were excessively sedentary or participated in heavy physical activity. All individuals were nonsmokers. Their body weight was stable for al last 3 months before the study.
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A randomized double blind, placebo controlled clinical trial was carried out in 21 drug naïve adults,regimen was prescribed to the subjects.
The allocation was 1:1 concealed and done by simple randomization using a table of random numbers. After randomization, 11 patients received of ASA 300 mg once daily and 10 patients received placebo (calcined magnesia) in the same pharmacological presentation for 90 days, the dose was based in the non-affectation of renal uric acid resorption.
| Calcined magnesia | Drug | Calcined magnesia 300 mg per capsule |
|
|
| 90 days |
| 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 |
| 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 |
| 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 |
| 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 |
| 21030723 | 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. |
| 21163347 | 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. |
| 15862133 | 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. |
| 23770795 | 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. |
| 17584843 | 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. |
| 16815474 | 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. |
| 21671857 | 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. |
| 10862819 | 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. |
| 2753525 | Background | Jeyaseelan L, Rao PS. Methods of determining sample sizes in clinical trials. Indian Pediatr. 1989 Feb;26(2):115-21. |
| 19337387 | 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. |
| 1623937 | 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. |
| 11121712 | 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. |
| 22521214 | 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. |
| 22252020 | 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. |
| 26224127 | 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. |
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| D004700 | Endocrine System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |