NCT02672826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

January 11, 2016

Last Update Submit

August 25, 2023

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • number of endothelial cells

    day 1

Secondary Outcomes (3)

  • number of senescent cells

    day 1

  • Correlation between estrogens level on endothelial senescence

    day 1

  • Correlation between endothelial senescence and activation state

    day 1

Study Arms (1)

adipose tissue surgery

EXPERIMENTAL

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

Interventions

Adipose tissue surgeryPROCEDURE

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

adipose tissue surgery

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Explorations fonctionnelles Physiologiques - Toulouse Hospital

Toulouse, 31059, France

Location

Related 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 Vasc Biol. 2023 May;43(5):684-696. doi: 10.1161/ATVBAHA.122.318876. Epub 2023 Mar 16.

    PMID: 36924232RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Francois ARNAL, MD PhD

    Explorations Fonctionnelles physiologiques

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

February 3, 2016

Study Start

June 1, 2013

Primary Completion

April 24, 2016

Study Completion

December 1, 2016

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)