Text Size

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

This study is currently recruiting participants.
Verified May 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01605578
First received: May 11, 2012
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
Adipose Tissue
 Procedure: Biopsies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Description Des Populations Cellulaires Des Tissus Adipeux Sous-cutanés Abdominaux et glutéo-fémoraux Chez la Femme.

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • To compare the number and the phenotype of cells between abdominal and gluteo-femoral adipose tissue in women. [ Time Frame: There is no time frame. It's a comparison of adipose tissue composition between two locations, collected both at visit 2 (inclusion). ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Biopsies
    Abdominal and gluteo-femoral subcutaneous adipose tissue biopsies
  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605578

Contacts
Contact: Claire Thalamas, Doctor +33(0)561779103

Locations
France
Centre d'Investigation Clinique, CHU Purpan Recruiting
Toulouse, France, 31059
Contact: Laurent Marquine     +33(0)561777638        
Principal Investigator: Claire Thalamas, Doctor            
Sub-Investigator: Monique Galitzky, Doctor            
Sub-Investigator: Fabienne Calvas, Doctor            
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Claire Thalamas, Doctor CHU Purpan
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01605578     History of Changes
Other Study ID Numbers: C11-48, 2011-A01496-35
Study First Received: May 11, 2012
Last Updated: May 21, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 23, 2013