Chronic Effects of Estrogen in Microcirculation

Postmenopausal Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295892
• Other study ID #: pkvw6k
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2011
• Last updated: April 17, 2013
• Start date: December 2011
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 48 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postmenopausal Symptoms

Intervention

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

Locations

Country	Name	City	State
Brazil	Laboratorio de Pesquisas Clinicas e Experimentais em Biologia Vascular	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional capillary density by videocapillaroscopy(number of perfused capillaries on the studied skin area)		03 months	No
Secondary	blood viscosity(the values are expressed in centipoises)	evaluate the change in blood viscosity after 3 months of treatment	03 months	No