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NCT Number: NCT00379704

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Louis Mourier

Colombes, 92701, France

About this study

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,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

TIFACT Study - Tissue Factor Expression by Adipose Tissue in Extremely Obese Subjects. Relationship With Circulating Tissue Factor and Coagulation Activation Markers

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 22, 2006
Registry last updated
Dec 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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