- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02672826
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
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
-
-
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Toulouse, France, 31059
- Explorations fonctionnelles Physiologiques - Toulouse Hospital
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-
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.
Sponsor
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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