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TIFACT Study – Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects.
This study is currently recruiting participants.
Study NCT00379704   Information provided by Assistance Publique - Hôpitaux de Paris
First Received: September 21, 2006   Last Updated: March 14, 2007   History of Changes

September 21, 2006
March 14, 2007
October 2006
 
 
 
Complete list of historical versions of study NCT00379704 on ClinicalTrials.gov Archive Site
 
 
 
TIFACT Study – Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects.
TIFACT Study – Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers

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.

Study design: it is a monocentric case/control study involving 60 obese subjects with a BMI  35 kg/m2 and 60 controls with a BMI between 18.5 and 25.

 
Observational
Screening, Cross-Sectional, Case Control, Prospective Study
Obesity
 
 
Samad F, Pandey M, Loskutoff DJ. Regulation of tissue factor gene expression in obesity. Blood. 2001 Dec 1;98(12):3353-8.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
October 2008
 

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
Both
18 Years to 55 Years
Yes
Contact: Alain STEPANIAN, MD,PhD +33(0)- 1 47 60 61 13 alain.stepanian@lmr.aphp.fr
France
 
NCT00379704
 
P060307
Assistance Publique - Hôpitaux de Paris
 
Principal Investigator: Alain STEPANIAN, MD PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP