Acetylsalicylic Acid and Type 2 Diabetes Mellitus

Centro Universitario de Ciencias de la Salud, Mexico

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2; Antioxidant Enzyme System

Treatments: Drug: Calcined magnesia; Drug: Acetylsalicylic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03341117

2345 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 35 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

Acetylsalicylic acid

Active Comparator group

Description:

The patients were randomly assigned to received Acetylsalicylic acid 300 mg once daily for 90 days

Treatment:

Drug: Acetylsalicylic acid

calcined magnesia

Placebo Comparator group

Description:

The patients were randomly assigned to received placebo (calcinaned magnesia), 1 capsule 300 mg before each meal for a period of 90 days.

Treatment:

Drug: Calcined magnesia