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NCT Number: NCT03341117

Acetylsalicylic Acid and Type 2 Diabetes Mellitus

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Antioxidant Enzyme System Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetylsalicylic acid

Drug

Acetylsalicylic acid 300 mg per capsule

Other names: Aspirin

calcined magnesia

Drug

Calcined magnesia 300 mg per capsule

Other names: Placebo

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

    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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Centro Universitario de Ciencias de la Salud, Mexico

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Nov 14, 2017
Registry last updated
Nov 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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