Circulating Endothelium Progenitor Cells and Endogenous Oestrogen in Healthy Subjects (Oestropec)

This study has been completed.
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00668252
First received: April 9, 2008
Last updated: April 28, 2008
Last verified: March 2006
  Purpose

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


Condition
Healthy

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Impact of Endogenous Sexual Hormones (Oestrogens and Testosterone) on the Endothelium Circulatory on Rolling at the Young and Old Healthy Volunteer.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of endothelial progenitor cells by cytometry [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

whole peripheral blood (150 ml)


Enrollment: 48
Study Start Date: April 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Non menopausal women
2
age matched men
3
Menopausal women
4
age matched 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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668252

Locations
France
Assistance Publique Hopitaux de Paris - Hopital Saint Antoine
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Tabassome Simon, MD - PhD Assistance Publique Hopitaux de Paris - Université Pierre et Marie Curie Paris 6
  More Information

No publications provided

Responsible Party: Yannick Vacher, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00668252     History of Changes
Other Study ID Numbers: P050904
Study First Received: April 9, 2008
Last Updated: April 28, 2008
Health Authority: France: Direction Générale de la Santé

Keywords provided by Assistance Publique - Hôpitaux de Paris:
endothelial progenitor cells
estrogen
menopause
cardiovascular risk

Additional relevant MeSH terms:
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014