NCT01525472

Brief Summary

Numerous epidemiological studies clearly showed the relationship between the excessive growth of visceral adipose tissue and risk of developing insulin resistance, type 2 diabetes and other cardiovascular risk factors. However, the mechanisms contributing to the deleterious role of visceral adipose tissue remain to be elucidated. Several observations suggest that adipose tissue depots exhibit distinct metabolic and secretory capacities according to their locations. We have recently shown that visceral fat depots display higher immuno-inflammatory cells infiltration than that of subcutaneous fat. In addition, the endothelial cells of visceral compared to subcutaneous adipose tissues express a pro-inflammatory phenotype and several markers related to aging. Finally, we have shown that visceral adipocyte-derived secretions promote the endothelial cell senescence in an extent higher than subcutaneous adipocyte-derived products. These data suggest that senescence 1) might be a phenomenon related to the location and therefore the microenvironment of adipose tissue and 2) might be responsible for an abnormal activation of proinflammatory response, favouring the development of metabolic and secretory dysfunction of adipose tissue in obesity. Our working hypothesis, based on these observations, is that the visceral adipose tissue provides a microenvironment that promotes accelerated aging. This senescence may be responsible for the establishment of an inflammatory reaction, alteration of the metabolic activity and adipocyte differentiation capacity of progenitor cells leading to the development of obesity associated diseases. The proposed project is a descriptive cross-sectional pathophysiological study .The aims are 1) to better define the process of senescence in human adipose tissue, 2) to precise the mechanisms and 3) to analyse the cellular and functional consequences of aging on inflammation, adipose tissue development and metabolism. 200 morbidly obese candidates for bariatric surgery will be studied. The collection of clinical and laboratory data and the collection of biological samples (plasma, blood cells and subcutaneous and visceral adipose tissues) will be made at the inclusion and during surgery (obesity center, Hôpital Louis Mourier). Analyses of adipose tissue will be performed at INSERM U1048 and will focus on in vitro approaches of the cells of the adipose tissues (mature adipocytes, endothelial cells, progenitor cells and immuno-inflammatory cells). This project will permit to better understand the pathogenicity associated with the excessive growth of visceral adipose tissue and may reveal new therapeutic targets to limit obesity-associated pathologies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

February 13, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2015

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3.6 years

First QC Date

February 1, 2012

Last Update Submit

August 27, 2021

Conditions

Keywords

obesityadipose tissueangiogenesissenecence

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital center

You may qualify if:

  • Age between 18 and 65 y
  • Social security insurance
  • Candidate for bariatric surgery based on criteria established by international experts (BMI\> 40 or\> 35 kg / m² with comorbidities, after failure of multidisciplinary care for a period of at least 1 year)
  • Patient having signed an informed consent

You may not qualify if:

  • Subject under guardian ship, curator ship or judicial protection.
  • Subject taking anti-inflammatory and / or non-steroidal drug
  • Current immunosuppressive therapy or interrupted for less than six months
  • malignancy or severe inflammatory disease evolving
  • Positive HIV serology and / or HBV and / or HCV
  • Current pregnancy
  • medical or psychiatric contraindication for bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Louis Mourier

Colombes, 92700, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

adipose tissue

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2012

First Posted

February 3, 2012

Study Start

February 13, 2012

Primary Completion

October 1, 2015

Study Completion

October 20, 2015

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations