Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

Assistance Publique - Hôpitaux de Paris48 enrolled

Overview

The purpose of this study is to determine whether the number of circulating EPC is different between healthy women and men.

Study design: Open pilot study in health volunteers in the Hospital Saint-ANTOINE's Clinical Investigation Centre (CIC). Recruitment and course of the study: The subjects will be recruited among the CIC's pool of healthy volunteers. Volunteer people will then have biological and clinical baseline examinations. If they match the inclusion criteria, an appointment will be taken for the blood sample intend for the characterization of the EPC and hormonal plasma levels evaluation. The participation will not exceed 2 months. Young women will have to come between the 9th and the 11th day after the beginning of menses). A total of 150 ml of peripheral blood will be collected. The study will last 18 months.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI between 19 and 25 kg/m² * non menopausal women : * age 18 to 40 years, * regular menstrual cycles * no hormone therapy as contraceptives * postmenopausal women : * age above 55 years old * amenorrhoea since 5 years at least * no hormone therapy since at least 3 month Exclusion Criteria: * no medical insurance * inclusion in another study * smoking, Statins treatment, uncontrolled diabetes or hypertension and personal history of cardiovascular disease.

Locations (1)

Assistance Publique Hopitaux de Paris - Hopital Saint Antoine

Paris, France

Outcomes

Primary Outcomes

Number of endothelial progenitor cells by cytometry

Time frame: Baseline

Secondary Outcomes

To compare the number of EPC in young women to older men and menopausal women. To evaluate the correlation between the number of EPC and 17 b-estradiol plasma level.

Time frame: Baseline

Data from ClinicalTrials.gov

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