Acetylsalicylic Acid Administered in Patients With Type 2 Diabetes Mellitus and Its Effect on the Antioxidant Enzyme System
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- 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
研究概览
简要总结
OBJETIVE To assess the effect of acetylsalicylic acid on antioxidant enzymatic system in patients with type 2 diabetes
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetes
- •BMI 25.0 - 35.0 kg/m2
- •HbA1c between 6.5 - 9%.
- •Written informed consent
- •Same residential area and socioeconomic status.
排除标准
- •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.
研究组 & 干预措施
Acetylsalicylic acid
The patients were randomly assigned to received Acetylsalicylic acid 300 mg once daily for 90 days
干预措施: Acetylsalicylic acid (Drug)
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.
干预措施: Calcined magnesia (Drug)
结局指标
主要结局
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
时间窗: 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.
次要结局
- Hepatic safety after the administration of acetylsalicylic acid through the determination of hepatic profile(90 days)
- Modification in lipid profile in patients with type 2 diabetes after the administration of Acetylsalicylic Acid(90 days)
- Renal safety of administration of acetylsalicylic acid through the determination of serum creatinine(90 days)
- Modification in fasting glucose in patients with type 2 diabetes after the administration of Acetylsalicylic acid(90 days)
- Modification in HbA1c in patients with type 2 diabetes after the administration of Acetylsalicylic Acid(90 days)
研究者
Sara Pascoe Gonzalez
PhD Clinical Research
Centro Universitario de Ciencias de la Salud, Mexico