Acetylsalicylic Acid and Type 2 Diabetes Mellitus

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

Detailed Description
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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).

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

Conditions
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Diabetes Mellitus, Type 2, Antioxidant Enzyme System

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Drug: Calcined magnesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetylsalicylic acid<br>The patients were randomly assigned to received Acetylsalicylic acid 300 mg once daily for 90 days | Drug: Acetylsalicylic acid<br>* Acetylsalicylic acid 300 mg per capsule<br>* Other names: Aspirin;|
| Placebo Comparator: calcined magnesia<br>The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule 300 mg before each meal for a period of 90 days. | Drug: Calcined magnesia<br>* Calcined magnesia 300 mg per capsule<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acetylsalicylic acid, antioxidant enzyme system, stress oxidative, type 2 diabetes mellitus.