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The Hypotensive Effect of Metformin in Hypertensive Patients.

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ClinicalTrials.gov Identifier: NCT02072382
Recruitment Status : Unknown
Verified August 2015 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : February 26, 2014
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
The proposed study is to evaluate the possible effect of metformin on arterial pressure by 24h-ambulatory blood pressure monitory (24h-ABPM).

Condition or disease Intervention/treatment Phase
Hypertension Drug: Metformin Drug: Placebo Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Hypotensive Effect of Simvastatin in Hypertensive Patients: a Placebo-controlled Randomized Clinical Trial With 24-h Ambulatory Blood Pressure Monitoring
Study Start Date : May 2013
Actual Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metformin
Metformin 850 mg twice a day for eight weeks versus Placebo
Drug: Metformin
metformin 850mg twice a day for eight weeks
Other Name: Glucophage

Drug: Placebo



Primary Outcome Measures :
  1. The effect of metformin on blood pressure [ Time Frame: eight weeks ]
    The primary outcome was the difference in mean 24-hour BP variation between the two groups (metformin versus placebo) after the intervention.


Secondary Outcome Measures :
  1. 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. [ Time Frame: eight weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hypertensive patients,
  • aged 18-75 years

Exclusion Criteria:

  • diabetes
  • metformin intolerance
  • creatinine level above 1.5 mg/dL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072382


Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil
Contact: Corrêa Junior Vicente    (51)99839395    vicentecorreajunior@terra.com.br   
Sub-Investigator: Correa Junior Vicente         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Study Chair: Gus Miguel Hospital de Clínicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02072382     History of Changes
Other Study ID Numbers: 120406
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: August 27, 2015
Last Verified: August 2015
Keywords provided by Hospital de Clinicas de Porto Alegre:
Hypertension
Metformin
Ambulatory blood pressure monitor
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Metformin
Antihypertensive Agents
Hypoglycemic Agents
Physiological Effects of Drugs