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Clinical Trial Details

Trial ID: L4236
Source ID: NCT03341117
Associated Drug: Acetylsalicylic Acid
Title: Acetylsalicylic Acid and Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Antioxidant Enzyme System
Interventions: DRUG: Acetylsalicylic acid|DRUG: Calcined magnesia
Outcome Measures: Primary: 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: Modification in lipid profile in patients with type 2 diabetes after the administration of Acetylsalicylic Acid, 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, 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, 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, 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, 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
Sponsor/Collaborators: Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 21
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2014-12-02
Completion Date: 2016-12-02
Results First Posted:
Last Update Posted: 2017-11-14
Locations:
URL: https://clinicaltrials.gov/show/NCT03341117