Description of Abdominal and Gluteo-femoral Subcutaneous Adipose Tissue Cell Population in Women - GLUTAB

Adipose Tissue Clinical Trial

Official title:

Description Des Populations Cellulaires Des Tissus Adipeux Sous-cutanés Abdominaux et glutéo-fémoraux Chez la Femme.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01605578
• Other study ID #: C11-48
• Secondary ID: 2011-A01496-35
• Status: Recruiting
• Phase: N/A
• First received: May 11, 2012
• Last updated: May 21, 2012
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Claire Thalamas, Doctor
• Phone: +33(0)561779103
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare, in healthy women, the adipose tissue composition between abdomen and thigh and then determine whether differences exist independently of the state of obesity.

The findings of this study may help to explain the mechanism contributing to a beneficial role of gluteo-femoral fat contrasting with a deleterious role of abdominal fat on cardiovascular and metabolic dysfunctions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• women between 15 and 45 years old

• with genital activity

• stable weight during the previous 3 months

• BMI from 20 to 28

• regular menstrual cycles (28 +/- 2 days) during the previous 3 months

• reliable means of contraception (systemic hormonal contraception, intrauterine contraceptive device, tubal ligation)

• using the same way of contraception during the previous 3 months

• normal clinical examination

• able to be compliant with the schedule of protocol assessments

• willing and able to provide written informed consent

• affiliated to a National Health Service

• agreeing to being registered on the national file for subjects participating in biomedical research

Exclusion Criteria:

• Exclusions related to significant medical disturbances :

• type I and II diabetes

• early menopause

• serious psychological disorders

• uncontrolled thyroid disorders

• know allergy to local anesthetics especially Xylocaine

• abnormal laboratory results

• medical history that, in the opinion of the investigator, makes the subject unsuitable for enrollment

• positive test result for HIV, HCV and/or HBV virus

• positive pregnancy test

• Exclusions related to subject lifestyle :

• smoking > 10 cigarettes per day

• smoking cessation during the previous 3 months

• weight fluctuation (>3kg) during the previous 3 months

• alcohol abuse

• coffee or tea consumption > 6 cups per day

• high consumption of drinks comprising xanthine bases (>0.5 liters/day)

• consumption of drinks (water or herbal teas) > 2 liters per day

• Exclusions related to previous or concomitant treatments :

• anticoagulant

• neuroleptic or antidepressant

• medication with draining, lipolytic, appetite suppressant and/or slimming effect

• local or systemic corticosteroid therapy on the test areas

• hormonal treatment other than contraception

• diuretic

• local treatment against cellulitis (mesotherapy,phosphatidylcholine injection, mechanical process)

• thighs liposuction < 2 years

• chronic treatment with anti-inflammatory

• Exclusions related to the subject :

• unwillingness or inability to comply with the requirements of the protocol

• previous participation in a clinical trial within 30 days

• inability to understand and sign the consent due to linguistic or psychic issues

• subject deprived of liberty or under guardianship, tutorship or judicial protection

• female who are currently pregnant or breastfeeding or female considering becoming pregnant while in the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Adipose Tissue

Intervention

Procedure:
• Biopsies
Abdominal and gluteo-femoral subcutaneous adipose tissue biopsies

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique, CHU Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the number and the phenotype of cells between abdominal and gluteo-femoral adipose tissue in women.		There is no time frame. It's a comparison of adipose tissue composition between two locations, collected both at visit 2 (inclusion).	No