Chronic Effects of Estrogen in Microcirculation

April 17, 2013 updated by: Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University

Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women

This study aims to evaluate the chronic effects of estrogen on microcirculation, inflammatory biomarkers, hormonal status, plasma viscosity and biochemical tests in postmenopausal obese women after three months of follow-up intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Estrogens exert pleiotropic actions on the cardiovascular system through binding to estrogen receptors. Traditionally, estrogen receptors have been recognized as transcription factors regulating the expression of target genes, however, numerous studies have revealed rapid actions of estrogen in different systems, so-called 'extranuclear actions'. At this level, estrogen triggers rapid vasodilatation, exerts anti-inflammatory effects, regulates vascular cell growth and migration, and confers protection to cardiomyocytes. Our aims are to investigate estrogen´s chronic effects on microcirculation.

The study will assess the potential benefits of estrogens on: chronic low-grade inflammation, metabolic profile, microcirculation and blood rheology. Postmenopausal obese women will be randomly submitted to estrogen (transdermal 17-β-estradiol 1mg/day) or placebo therapy during three months in a double-blind fashion. At baseline and after intervention, nailfold videocapillaroscopy, laser-Doppler flowmetry and venous occlusion plethysmography, inflammatory biomarkers, hormonal status, metabolic profile, plasma viscosity and anthropometrical measures will be assessed in all subjects.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • History of natural menopause defined by the absence of menses for at least 12 months and a serum concentration of FSH > 35 IU/L
  • BMI between 27 to 34.9 kg/m²
  • Non-smokers
  • Not on use of any hormones or supplements for a minimum of 6 months prior to the study
  • No absolute contraindications to the use of physiological replacement doses of estrogen

Exclusion Criteria:

  • Renal disease, coronary or peripheral vascular diseases, haematologic or hepatic diseases
  • Diabetes mellitus, glucose intolerance or altered fasting glucose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
placebo (transdermal gel)
Drug: Estrogen
transdermal 17-β-estradiol 1mg/day during three months
Experimental: Estrogen
1mg of 17B-estradiol/day (transdermal gel)
Drug: Estrogen
transdermal 17-β-estradiol 1mg/day during three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)
Time Frame: 03 months
03 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood viscosity(the values are expressed in centipoises)
Time Frame: 03 months
evaluate the change in blood viscosity after 3 months of treatment
03 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rio de Janeiro State University

Investigators

  • Principal Investigator: Diogo Panazzolo, Rio de Janeiro State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pkvw6k

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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