Status:
TERMINATED
ENDOBARRIER® and Conventional Therapy in the Management of Metabolic Syndrome in Obese Patients
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
20-60 years
Phase:
NA
Brief Summary
Obesity and metabolic syndrome (MS) are closely interrelated leading to increased mortality, mainly due to cardiovascular disease. In addition, some cancers are much higher when obesity is associated ...
Detailed Description
Obesity, defined as a body mass index (BMI) over 30 kg / m², has now affected more than 14% of the French population. This condition is associated with several co-morbidities, and increased mortality,...
Eligibility Criteria
Inclusion
- Clinical diagnosis of Metabolic Syndrome defined by the presence of at least 3 of the 5 factors identified in the harmonization of the definition of metabolic syndrome by the International Diabetes Federation, the American Heart Association and the National Heart, Lung and Blood Institute
- BMI \> 30 kg/m2
- The subject must be a candidate for general anesthesia
- The subject must be able to understand the options to comply with the requirement of each intervention program.
- Non-pregnant female patients must agree to use a reliable method of contraception for 2 years
Exclusion
- Contraindications from the notice of ENDOBARRIER device
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02297555
Start Date
April 1 2014
End Date
October 1 2017
Last Update
May 18 2018
Active Locations (10)
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1
Hôpital Avicenne
Bobigny, France
2
Hopital Ambroise Pare (Ap-Hp)
Boulogne-Billancourt, France
3
Hopital Louis Mourier
Colombes, France
4
University Hospital Lille
Lille, France, 59000