Chronic Effects of Estrogen in Microcirculation

Overview

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.

Full Title of Study: “Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2013

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.

Interventions

  • Drug: Estrogen
    • transdermal 17-β-estradiol 1mg/day during three months

Arms, Groups and Cohorts

  • Placebo Comparator: placebo
    • placebo (transdermal gel)
  • Experimental: Estrogen
    • 1mg of 17B-estradiol/day (transdermal gel)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 48 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rio de Janeiro State University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luiz Guilherme Kraemer de Aguiar, Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women – Rio de Janeiro State University
  • Overall Official(s)
    • Diogo Panazzolo, Principal Investigator, Rio de Janeiro State University

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