The Hypotensive Effect of Metformin in Hypertensive Patients.
The Hypotensive Effect of Simvastatin in Hypertensive Patients: a Placebo-controlled Randomized Clinical Trial With 24-h Ambulatory Blood Pressure Monitoring
研究概览
详细说明
The primary outcome was the difference in mean 24-hour blood pressure variation between the two groups after the intervention. The difference in mean of blood pressure during daytime and nighttime in 24h ambulatory blood pressure monitory, as well as the office BP and laboratory differences were considered secondary outcomes.
This randomized, double-blind parallel study was conducted in the Hypertension Clinic of the Department of Cardiology, Hospital de Clínicas de Porto Alegre (Porto Alegre, Brazil).
We selected hypertensive individuals (controlled or not) without diabetes aged 18-70 years.
Exclusion criteria: metformin intolerance, creatinine > 1,5 mg/dl Risks: adverse effects related to metformin use, mainly diarrhea and nausea Benefits: possible lower effect on arterial pressure Statistical analysis: sample size was calculated on the basis of a standard deviation of 8 mm Hg and effect size of 5 mm Hg in 24-h systolic ABPM and a two-sided significance level of 5%. A sample size of 42 patients per group was estimated to provide a power of 80% to reject the null hypothesis. Considering possible 10% of losses, the final calculated sample was 92 patients.
The baseline comparison between groups was performed using the Student t test for continuous variables and x2 for categorical variables. In each group, the change in BP by ABPM -24 h, daytime and nighttime, and laboratory tests was calculated by subtracting baseline values measured after the intervention period. The difference between groups was calculated by subtracting the variation observed between them (δ-values). The differences in BP variation and laboratory tests were analyzed by analysis of variance for repeated measures (MANOVA). For differences in pressure variation adjustment was considered for the baseline BP values (analysis of covariance). All tests were two-tailed and significance level was 5%. Data were analyzed using Statistical Package for the Social Sciences (SPSS) version 13.0.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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-
RS
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Porto Alegre、RS、巴西
- 招聘中
- Hospital de Clinicas de Porto Alegre
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接触:
- Corrêa Junior Vicente
- 电话号码:(51)99839395
- 邮箱:vicentecorreajunior@terra.com.br
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副研究员:
- Correa Junior Vicente
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- hypertensive patients,
- aged 18-75 years
Exclusion Criteria:
- diabetes
- metformin intolerance
- creatinine level above 1.5 mg/dL
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Metformin
Metformin 850 mg twice a day for eight weeks versus Placebo
|
metformin 850mg twice a day for eight weeks
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
The effect of metformin on blood pressure
大体时间:eight weeks
|
The primary outcome was the difference in mean 24-hour BP variation between the two groups (metformin versus placebo) after the intervention.
|
eight weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
The difference in mean of BP during daytime and nighttime in ABPM-24h, as well as the office BP and laboratory differences were considered secondary outcomes.
大体时间:eight weeks
|
eight weeks
|
合作者和调查者
调查人员
- 学习椅:Gus Miguel、Hospital de Clinicas de Porto Alegre
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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