Acetylsalicylic Acid and Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2; Antioxidant Enzyme System
• Interventions: Drug: Calcined magnesia; Drug: Acetylsalicylic acid

• Registration Number: NCT03341117
• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

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).

Study Timeline

• Study Start: 2014-12-02
• Primary Completion: 2015-12-02
• Study Completion: 2016-12-02
• Study First Submitted: 2017-09-22
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-08
• Last Update Submitted: 2017-11-08
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
calcined magnesia	Calcined magnesia	The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule 300 mg before each meal for a period of 90 days.
Acetylsalicylic acid	Acetylsalicylic acid	The patients were randomly assigned to received Acetylsalicylic acid 300 mg once daily for 90 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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.
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.