Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects

NCT ID: NCT00668252

Last Updated: 2008-04-29

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

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Keywords

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endothelial progenitor cells estrogen menopause cardiovascular risk

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Non menopausal women

No interventions assigned to this group

2

age matched men

No interventions assigned to this group

3

Menopausal women

No interventions assigned to this group

4

age matched men

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpement

Principal Investigators

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Tabassome Simon, MD - PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux de Paris - Université Pierre et Marie Curie Paris 6

Locations

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Assistance Publique Hopitaux de Paris - Hopital Saint Antoine

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P050904

Identifier Type: -

Identifier Source: org_study_id