Acetylsalicylic Acid and Type 2 Diabetes Mellitus

Overview

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

Full Title of Study: “Acetylsalicylic Acid Administered in Patients With Type 2 Diabetes Mellitus and Its Effect on the Antioxidant Enzyme System”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2, 2015

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

  • Drug: Acetylsalicylic acid
    • Acetylsalicylic acid 300 mg per capsule
  • Drug: Calcined magnesia
    • Calcined magnesia 300 mg per capsule

Arms, Groups and Cohorts

  • Active Comparator: Acetylsalicylic acid
    • The patients were randomly assigned to received Acetylsalicylic acid 300 mg once daily for 90 days
  • Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 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 Measures

  • Modification in lipid profile in patients with type 2 diabetes after the administration of Acetylsalicylic Acid
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Centro Universitario de Ciencias de la Salud, Mexico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Sara Pascoe Gonzalez, PhD Clinical Research – Centro Universitario de Ciencias de la Salud, Mexico

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