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Completed

NCT Number: NCT01295892

Chronic Effects of Estrogen in Microcirculation

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.

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Key information

Age range

48 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular

Rio de Janeiro, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estrogen

Drug

transdermal 17-β-estradiol 1mg/day during three months

Primary outcomes

  1. functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)

    Time frame: 03 months

Secondary outcomes

  1. blood viscosity(the values are expressed in centipoises)

    Time frame: 03 months

    evaluate the change in blood viscosity after 3 months of treatment

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 15, 2011
Registry last updated
Apr 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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