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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01605578
Recruitment Status : Unknown
Verified May 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : May 25, 2012
Last Update Posted : May 25, 2012
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.

Condition or disease Intervention/treatment Phase
Adipose Tissue Procedure: Biopsies Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Description Des Populations Cellulaires Des Tissus Adipeux Sous-cutanés Abdominaux et glutéo-fémoraux Chez la Femme.
Study Start Date : May 2012
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2014

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

Primary Outcome Measures :
  1. 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). ]

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01605578

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

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
Principal Investigator: Claire Thalamas, Doctor CHU Purpan (Toulouse)

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France Identifier: NCT01605578     History of Changes
Other Study ID Numbers: C11-48
2011-A01496-35 ( Registry Identifier: IDRCB )
First Posted: May 25, 2012    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012