We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00379704
Recruitment Status : Completed
First Posted : September 22, 2006
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Obesity

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,


Study Design

Study Type : Observational
Actual Enrollment : 85 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers
Study Start Date : October 2006
Primary Completion Date : October 2010
Study Completion Date : October 2010
Groups and Cohorts


Outcome Measures

Biospecimen Retention:   Samples Without DNA
samples of plasma and serum and greasy fragments

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379704


Locations
France
CHU Louis Mourier
Colombes, France, 92701
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Alain STEPANIAN, MD PH Assistance Publique - Hôpitaux de Paris
More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00379704     History of Changes
Other Study ID Numbers: P060307
First Posted: September 22, 2006    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Tissue factor
Obesity
Adipose tissue
Microparticles

Additional relevant MeSH terms:
Thromboplastin
Hemostatics
Coagulants