TIFACT Study – Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00379704

Purpose

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
Obesity

MedlinePlus related topics: Obesity

Drug Information available for: Thromboplastin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Case Control, Prospective Study
Official Title:	TIFACT Study – Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Estimated Enrollment:	120
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2008

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379704

Contacts

Contact: Alain STEPANIAN, MD,PhD

+33(0)- 1 47 60 61 13

alain.stepanian@lmr.aphp.fr

Locations

France
CHU Louis Mourier	Recruiting
Colombes, France, 92701
Contact: Alain STEPANIAN, MD,PhD +33(0)- 1 47 60 61 13 alain.stepanian@lmr.aphp.fr
Principal Investigator: Alain STEPANIAN, M

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Alain STEPANIAN, MD PH

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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

Study ID Numbers:	P060307
Study First Received:	September 21, 2006
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00379704
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Tissue factor
Obesity
Adipose tissue
Microparticles

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Thromboplastin

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Coagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on January 14, 2009