Chronic Effects of Estrogen in Microcirculation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Postmenopausal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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placebo

placebo (transdermal gel)

Group Type PLACEBO_COMPARATOR

Estrogen

Intervention Type DRUG

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

Estrogen

1mg of 17B-estradiol/day (transdermal gel)

Group Type EXPERIMENTAL

Estrogen

Intervention Type DRUG

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

Interventions

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Estrogen

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

48 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No