Antioxidant Enzyme System, Diabetes Mellitus, Type 2
Conditions
Keywords
acetylsalicylic acid, antioxidant enzyme system, stress oxidative, type 2 diabetes mellitus.
Brief summary
OBJETIVE To assess the effect of acetylsalicylic acid on antioxidant enzymatic system in patients with type 2 diabetes
Detailed 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).
Interventions
DRUGAcetylsalicylic acid
Acetylsalicylic acid 300 mg per capsule
Calcined magnesia 300 mg per capsule
Sponsors
Centro Universitario de Ciencias de la Salud, Mexico
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modification in lipid profile in patients with type 2 diabetes after the administration of Acetylsalicylic Acid | 90 days | 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. |
| Hepatic safety after the administration of acetylsalicylic acid through the determination of hepatic profile | 90 days | 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. |
| Renal safety of administration of acetylsalicylic acid through the determination of serum creatinine | 90 days | 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. |
| Modification in HbA1c in patients with type 2 diabetes after the administration of Acetylsalicylic Acid | 90 days | 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. |
| Modification in fasting glucose in patients with type 2 diabetes after the administration of Acetylsalicylic acid | 90 days | 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. |
Outcome results
None listed