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Description of the Endothelial Phenotypes From the Subcutaneous Abdominal and Gluteo-femoral Adipose Tissues in Women (ADIPENDO)

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.
 
ClinicalTrials.gov Identifier: NCT02672826
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : November 21, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date November 21, 2017
Actual Study Start Date  ICMJE June 1, 2013
Actual Primary Completion Date April 24, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2016)
number of endothelial cells [ Time Frame: day 1 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2016)
  • number of senescent cells [ Time Frame: day 1 ]
  • Correlation between estrogens level on endothelial senescence [ Time Frame: day 1 ]
  • Correlation between endothelial senescence and activation state [ Time Frame: day 1 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Description of the Endothelial Phenotypes From the Subcutaneous Abdominal and Gluteo-femoral Adipose Tissues in Women
Official Title  ICMJE Description of the Endothelial Phenotypes From the Subcutaneous Abdominal and Gluteo-femoral Adipose Tissues in Women
Brief Summary The endothelium is a key barrier between blood and tissue compartments. It is a major target of factors involved in metabolic and cardiovascular pathologies. However, the study of native human adult endothelial cells is difficult due to the lack of appropriate models and thereafter the endothelium is actually not easily accessible for clinical investigation. However, our results recently showed that the endothelium from human adipose tissue exhibit distinct phenotypes, including endothelial cell number and inflammatory, angiogenic and senescent state, according to adipose tissue location, i.e. subcutaneous and visceral. It is well recognized that estrogens favour gluteo-femoral adipose tissue deposit and their deficit after menopause is associated with increased abdominal and visceral fat mass as well as metabolic dysfunctions. These perturbations might be prevented with hormonal therapy. However, no data are available concerning the endothelial cells from gluteo-femoral and abdominal adipose tissues in women.
Detailed Description The adipose tissues (gluteo-femoral and abdominal) will be obtained from women programmed for surgery in which the estrogenic status as well as adipose tissue mass profile will be evaluated. The phenotype (inflammatory and angiogenic activation and senescent state) of native endothelial cells will be determined "in situ" by immunohistochemical and flow cytometry approaches and on isolated endothelial cells by Reverse transcriptase-Q Polymerase Chain Reaction and Western blot. In vitro approaches will be performed 1) to establish a causal relationship between endothelial senescence and activation state, 2) to define the impact of the adipose tissue microenvironment on the endothelial cell activation and senescence and 3) to study the potential protective effect of estrogens on endothelial senescence.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Obesity
Intervention  ICMJE Procedure: Adipose tissue surgery
Adipose tissue (gluteo-femoral and abdominal) will be obtained from women programmed for surgery in which the estrogenic status as well as adipose tissue mass profile will be evaluated
Study Arms  ICMJE Experimental: adipose tissue surgery
The adipose tissue surgery (gluteo-femoral and abdominal) will be obtained from women programmed for surgery in which the estrogenic status as well as adipose tissue mass profile will be evaluated.
Intervention: Procedure: Adipose tissue surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2016)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date April 24, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stable weight for at least 3 months
  • Women undergoing a surgery of subcutaneous adipose tissue

Exclusion Criteria:

  • Undergoing Insulin therapy
  • Undergoing steroidal and nonsteroidal anti-inflammatory treatments
  • undergoing or stopped since less than 6 months immunosuppressive treatments
  • Positive serology for HIV, Hepatitis B Virus and/or Hepatitis C Virus
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672826
Other Study ID Numbers  ICMJE 12 067 08
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Investigators  ICMJE
Principal Investigator: Jean-Francois ARNAL, MD PhD Explorations Fonctionnelles physiologiques
PRS Account University Hospital, Toulouse
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP