TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects.
1 other identifier
observational
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2006
CompletedFirst Posted
Study publicly available on registry
September 22, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 8, 2011
March 1, 2007
4 years
September 21, 2006
December 7, 2011
Conditions
Keywords
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
You may qualify if:
- BMI \> 35
- Stable obesity
- Abdominal or pelvic surgery
- Agree to participate to the study
You may not qualify if:
- malignancy,
- infectious or inflammatory disease, notably HIV infection
- pregnancy
- history of ischemic cardio or neurovascular event, lower limb arteritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Louis Mourier
Colombes, 92701, France
Related Publications (1)
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.
PMID: 11719374BACKGROUND
Biospecimen
samples of plasma and serum and greasy fragments
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alain STEPANIAN, MD PH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2006
First Posted
September 22, 2006
Study Start
October 1, 2006
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 8, 2011
Record last verified: 2007-03