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

August 25, 2023 updated by: University Hospital, Toulouse
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31059
        • Explorations fonctionnelles Physiologiques - Toulouse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of endothelial cells
Time Frame: day 1
day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
number of senescent cells
Time Frame: day 1
day 1
Correlation between estrogens level on endothelial senescence
Time Frame: day 1
day 1
Correlation between endothelial senescence and activation state
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean-Francois ARNAL, MD PhD, Explorations Fonctionnelles physiologiques

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

April 24, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 31, 2016

First Posted (Estimated)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 12 067 08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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