Chronic Effects of Estrogen in Microcirculation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luiz Guilherme Kraemer de Aguiar, Rio de Janeiro State University
ClinicalTrials.gov Identifier:
NCT01295892
First received: February 14, 2011
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Postmenopausal Symptoms
Drug: Estrogen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women

Resource links provided by NLM:


Further study details as provided by Rio de Janeiro State University:

Primary Outcome Measures:
  • functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area) [ Time Frame: 03 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood viscosity(the values are expressed in centipoises) [ Time Frame: 03 months ] [ Designated as safety issue: No ]
    evaluate the change in blood viscosity after 3 months of treatment


Enrollment: 44
Study Start Date: December 2011
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   48 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295892

Locations
Brazil
Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular
Rio de Janeiro, Brazil
Sponsors and Collaborators
Rio de Janeiro State University
Investigators
Principal Investigator: Diogo Panazzolo Rio de Janeiro State University
  More Information

No publications provided

Responsible Party: Luiz Guilherme Kraemer de Aguiar, Chronic Effects of Estrogen in Microcirculation and Insulin Resistance in Postmenopausal Obese Women, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT01295892     History of Changes
Other Study ID Numbers: pkvw6k
Study First Received: February 14, 2011
Last Updated: April 17, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Rio de Janeiro State University:
menopause
obesity
capillary
microcirculation
estrogen
Microvascular Function

Additional relevant MeSH terms:
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014