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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02672826
Other study ID # 12 067 08
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2013
Est. completion date December 2016

Study information

Verified date August 2023
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2016
Est. primary completion date April 24, 2016
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Explorations fonctionnelles Physiologiques - Toulouse Hospital Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Toulouse Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Aupetit A, Decaunes P, Belles C, Riant E, Galitzky J, Chapouly C, Laisne M, Flores-Flores R, Chaput B, Vie K, Arnal JF, Bouloumie A, Briot A. Endothelial DLL4 Is an Adipose Depot-Specific Fasting Sensor Regulating Fatty Acid Fluxes. Arterioscler Thromb Va — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary number of endothelial cells day 1
Secondary number of senescent cells day 1
Secondary Correlation between estrogens level on endothelial senescence day 1
Secondary Correlation between endothelial senescence and activation state day 1
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