Acetylsalicylic Acid and Type 2 Diabetes Mellitus

November 8, 2017 updated by: Sara Pascoe Gonzalez, Centro Universitario de Ciencias de la Salud, Mexico

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetylsalicylic acid
The patients were randomly assigned to received Acetylsalicylic acid 300 mg once daily for 90 days
Drug: Acetylsalicylic acid
Acetylsalicylic acid 300 mg per capsule
Other Names:
  • Aspirin
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.
Drug: Calcined magnesia
Calcined magnesia 300 mg per capsule
Other Names:
  • Placebo

What is the study measuring?

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
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.
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
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.
90 days
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.
90 days
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.
90 days
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.
90 days
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2014

Primary Completion (Actual)

December 2, 2015

Study Completion (Actual)

December 2, 2016

Study Registration Dates

First Submitted

September 22, 2017

First Submitted That Met QC Criteria

November 8, 2017

First Posted (Actual)

November 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 8, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2345 (University of Debrecen, RKEB/IKEB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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