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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00379704
First received: September 21, 2006
Last updated: December 7, 2011
Last verified: March 2007

September 21, 2006
December 7, 2011
October 2006
October 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00379704 on ClinicalTrials.gov Archive Site
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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.

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,

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

samples of plasma and serum and greasy fragments

Probability Sample

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
Obesity
Not Provided
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
October 2010
October 2010   (final data collection date for primary outcome measure)

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 information is only displayed when the study is recruiting subjects
France
 
NCT00379704
P060307
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
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