TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-10-31

Brief Summary

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Tissue factor is the main activator of coagulation cascades. Excessive tissue factor expression is made responsible of thrombosis in a number of clinical situations including thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor gene expression in adipose tissue was significantly increased in obese versus lean mice.

The main objective of this study is to show that tissue factor expression is increased in human adipose tissue obtained from obese subjects and to identify its main tissular origin by comparing abdominal and subcutaneous adipose tissue.

The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue factor expressed by adipose tissue, (ii) the amount of subcutaneous and profound adipose tissue, and (iii) coagulation activation markers.

Detailed Description

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Tissue factor is the main activator of coagulation cascades. Excessive tissue factor expression is made responsible of thrombosis in a number of clinical situations including thrombosis in contact with atherosclerotic plaques. Recent work showed that tissue factor gene expression in adipose tissue was significantly increased in obese versus lean mice.

The main objective of this study is to show that tissue factor expression is increased in human adipose tissue obtained from obese subjects and to identify its main tissular origin by comparing abdominal and subcutaneous adipose tissue.

The secondary objectives are to identify the cell origin of tissue factor (adipocytes versus stromal cells) and to analyze the relation ship between blood tissue factor and (i) tissue factor expressed by adipose tissue,

Conditions

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Obesity

Keywords

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Tissue factor Obesity Adipose tissue Microparticles

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* BMI \> 35
* Stable obesity
* Abdominal or pelvic surgery
* Agree to participate to the study

Exclusion Criteria

* malignancy,
* infectious or inflammatory disease, notably HIV infection
* pregnancy
* history of ischemic cardio or neurovascular event, lower limb arteritis

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain STEPANIAN, MD PH

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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CHU Louis Mourier

Colombes, , France

Site Status

Countries

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France

References

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Samad F, Pandey M, Loskutoff DJ. Regulation of tissue factor gene expression in obesity. Blood. 2001 Dec 1;98(12):3353-8. doi: 10.1182/blood.v98.12.3353.

Reference Type BACKGROUND

PMID: 11719374 (View on PubMed)

Other Identifiers

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P060307

Identifier Type: -

Identifier Source: org_study_id