Clinical trial NCT03341117: Acetylsalicylic Acid and Type 2 Diabetes Mellitus
Official title: Acetylsalicylic Acid Administered in Patients With Type 2 Diabetes Mellitus and Its Effect on the Antioxidant Enzyme System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Antioxidant Enzyme System
Keywords: acetylsalicylic acid
antioxidant enzyme system
stress oxidative
type 2 diabetes mellitus.
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 21
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 90 days
Secondary outcomes:
measure: Modification in lipid profile in patients with type 2 diabetes after the administration of Acetylsalicylic Acid
timeFrame: 90 days
measure: Hepatic safety after the administration of acetylsalicylic acid through the determination of hepatic profile
timeFrame: 90 days
measure: Renal safety of administration of acetylsalicylic acid through the determination of serum creatinine
timeFrame: 90 days
measure: Modification in HbA1c in patients with type 2 diabetes after the administration of Acetylsalicylic Acid
timeFrame: 90 days
measure: Modification in fasting glucose in patients with type 2 diabetes after the administration of Acetylsalicylic acid
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
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