Clinical trial NCT00379704: TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects.
Official title: TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Tissue factor
Obesity
Adipose tissue
Microparticles
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-09-22
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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: 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,

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Colombes
country: France
facility: CHU Louis Mourier
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain STEPANIAN, MD PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.