Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00668252

Acronym

Oestropec

Enrollment

Registered

2008-04-29

Start date

2006-04-30

Completion date

2007-04-30

Last updated

2008-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

endothelial progenitor cells, estrogen, menopause, cardiovascular risk

Brief summary

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

Detailed description

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.

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Number of endothelial progenitor cells by cytometry	Baseline

Secondary

Measure	Time frame
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.	Baseline

Countries

France

Outcome results