The Hypotensive Effect of Metformin in Hypertensive Patients.

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Chair: Gus Miguel; Hospital de Clínicas de Porto Alegre

More Information

• Responsible Party: Hospital de Clinicas de Porto Alegre
• ClinicalTrials.gov Identifier: NCT02072382
• Other Study ID Numbers: 120406
• First Posted: February 26, 2014
• 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:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Metformin; Hypoglycemic Agents; Physiological Effects of Drugs