Acetylsalicylic Acid and Type 2 Diabetes Mellitus

NCT03341117 | Completed Phase 3

• 1 other identifier: 2345
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2; Antioxidant Enzyme System

Keywords

acetylsalicylic acid; antioxidant enzyme system; stress oxidative; type 2 diabetes mellitus.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  90 days

• Hepatic safety after the administration of acetylsalicylic acid through the determination of hepatic profile

  90 days

• Renal safety of administration of acetylsalicylic acid through the determination of serum creatinine

  90 days

• Modification in HbA1c in patients with type 2 diabetes after the administration of Acetylsalicylic Acid

  90 days

• Modification in fasting glucose in patients with type 2 diabetes after the administration of Acetylsalicylic acid

  90 days

Study Arms (2)

Acetylsalicylic acid

ACTIVE COMPARATOR

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

Drug: Acetylsalicylic acid

calcined magnesia

PLACEBO COMPARATOR

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

Interventions

Acetylsalicylic acid DRUG

Acetylsalicylic acid 300 mg per capsule

Also known as: Aspirin

Acetylsalicylic acid

Calcined magnesia DRUG

Calcined magnesia 300 mg per capsule

Also known as: Placebo

calcined magnesia

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Type 2 Diabetes
• BMI 25.0 - 35.0 kg/m2
• HbA1c between 6.5 - 9%.
• Written informed consent
• Same residential area and socioeconomic status.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead

Related Publications (21)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A randomized double blind, placebo controlled clinical trial was carried out in 21 drug naïve adults,regimen was prescribed to the subjects. The allocation was 1:1 concealed and done by simple randomization using a table of random numbers. After randomization, 11 patients received of ASA 300 mg once daily and 10 patients received placebo (calcined magnesia) in the same pharmacological presentation for 90 days, the dose was based in the non-affectation of renal uric acid resorption.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Clinical Research

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: November 14, 2017
• Study Start: December 2, 2014
• Primary Completion: December 2, 2015
• Study Completion: December 2, 2016
• Last Updated: November 14, 2017

Record last verified: 2017-11