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

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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

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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Adipose tissue surgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Description of the Endothelial Phenotypes From the Subcutaneous Abdominal and Gluteo-femoral Adipose Tissues in Women
Actual Study Start Date : June 1, 2013
Actual Primary Completion Date : April 24, 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. number of endothelial cells [ Time Frame: day 1 ]

Secondary Outcome Measures :
  1. number of senescent cells [ Time Frame: day 1 ]
  2. Correlation between estrogens level on endothelial senescence [ Time Frame: day 1 ]
  3. Correlation between endothelial senescence and activation state [ Time Frame: day 1 ]


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02672826


Locations
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France
Explorations fonctionnelles Physiologiques - Toulouse Hospital
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Jean-Francois ARNAL, MD PhD Explorations Fonctionnelles physiologiques
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02672826    
Other Study ID Numbers: 12 067 08
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No