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Acetylsalicylic Acid and Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03341117
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sara Pascoe Gonzalez, Centro Universitario de Ciencias de la Salud, Mexico

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Antioxidant Enzyme System Drug: Acetylsalicylic acid Drug: Calcined magnesia Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
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.
Masking: Double (Participant, Investigator)
Masking Description:

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.

Primary Purpose: Treatment
Official Title: Acetylsalicylic Acid Administered in Patients With Type 2 Diabetes Mellitus and Its Effect on the Antioxidant Enzyme System
Actual Study Start Date : December 2, 2014
Actual Primary Completion Date : December 2, 2015
Actual Study Completion Date : December 2, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

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 Name: 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 Name: Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications:

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Responsible Party: Sara Pascoe Gonzalez, PhD Clinical Research, Centro Universitario de Ciencias de la Salud, Mexico
ClinicalTrials.gov Identifier: NCT03341117     History of Changes
Other Study ID Numbers: 2345
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara Pascoe Gonzalez, Centro Universitario de Ciencias de la Salud, Mexico:
acetylsalicylic acid
antioxidant enzyme system
stress oxidative
type 2 diabetes mellitus.

Additional relevant MeSH terms:
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Aspirin
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Antioxidants
Magnesium Oxide
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Antacids
Gastrointestinal Agents