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| Tracking Information | |||||
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| First Received Date ICMJE | September 21, 2006 | ||||
| Last Updated Date | March 14, 2007 | ||||
| Start Date ICMJE | October 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00379704 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | TIFACT Study – Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. | ||||
| Official Title ICMJE | TIFACT Study – Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Screening, Cross-Sectional, Case Control, Prospective Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | Samad F, Pandey M, Loskutoff DJ. Regulation of tissue factor gene expression in obesity. Blood. 2001 Dec 1;98(12):3353-8. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Enrollment ICMJE | 120 | ||||
| Completion Date | October 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00379704 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | P060307 | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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