Clinical trial NCT02297555: ENDOBARRIER® and Conventional Therapy in the Management of Metabolic Syndrome in Obese Patients
Official title: ENDOBARRIER® vs Conventional Therapy in the Management of Metabolic Syndrome in Obese Patients. Medico-economic Analysis as Part of a Randomized Controlled Multicenter Trial - ENDOMETAB
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Obesity
Metabolic Syndrome
ENDOBARRIER®
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2014-11-21
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 with metabolic syndrome. Bariatric surgery allows significant and sustained weight loss with marked improvement of MS. Considered too invasive, surgery is proposed to a small proportion of patients who could theoretically benefit. The ENDOBARRIER® device implanted endoscopically is an innovative approach developed for management of obesity in the non-surgical manner with benefits for improvement in MS already reported in literature.

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, mainly due to cardiovascular disease and some cancers. These risks are much higher when obesity is associated with metabolic syndrome.

Conventional medical care for metabolic syndrome, even conducted by multidisciplinary teams combining dietary advice, physical activity and psychological treatment offers only limited results, both in weight reduction and comorbidities. Bariatric surgery allows however a significant and sustained weight loss in the majority of cases, and a decrease in the frequency and severity of co-morbidities, including type 2 diabetes, and decreased mortality including cardiovascular. Considered too invasive by many practitioners and patients, surgery is therefore proposed to a small proportion of patients who could theoretically benefit.

The results of surgery have, however, validated the principle of the interventional treatment of obesity and its metabolic complications.

Different techniques that may replace surgery are currently being developed. Among these new approaches, the most successful is the device "endoluminal liner ENDOBARRIER®" (GI Dynamics ™, Boston, USA). The ENDOBARRIER® device could represent a major innovation in the non-surgical management of obesity. The benefits of installing the device on the morbidity associated with obesity are reported in the literature: impact on hypertension, diabetes, dyslipidemia and metabolic syndrome as such.

This trial will compare in a randomized study the results, tolerance and cost of the interventional therapy with the device ENDOBARRIER® over conventional therapy in French patients with obesity and metabolic syndrome, with or without diabetes. The evaluation of the cost-effectiveness of this device will clarify its role in the strategy for the management of obesity and its comorbidities.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Contraindications from the notice of ENDOBARRIER device

Primary outcomes:
measure: Frequency of patients without Metabolic Syndrome
timeFrame: 12 month
Secondary outcomes:
measure: The level of insulin resistance
timeFrame: 12 months, 24 months
measure: Changed in cardiovascular risk assessed by Framingham Risk Score
timeFrame: 12 months, 24 months
measure: Changed in quality of life
timeFrame: 12 months, 24 months
measure: Rate of adverse events
timeFrame: 12 months, 24 months
measure: The cost-benefit ratio for each group
timeFrame: 12 months, 24 months
measure: Changed in blood pressure
timeFrame: 12 months, 24 months
measure: Changed in blood sugar
timeFrame: 12 months, 24 months
measure: Changed in triglycerides
timeFrame: 12 months, 24 months
measure: Changed in HDL
timeFrame: 12 months, 24 months
measure: Changed in waist circumference
timeFrame: 12 months, 24 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hôpital Avicenne
city: Boulogne Billancourt
country: France
facility: Hopital Ambroise Pare (Ap-Hp)
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Lille
country: France
facility: University Hospital Lille
city: Lyon
country: France
facility: Hospice civils de Lyon
city: Marseille
country: France
facility: Assistance Publique des Hôpitaux de Marseille
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire
city: Nantes
country: France
facility: Centre Hospitalier Universitaire
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Toulouse
country: France
facility: Hopital Larrey- Chu
Study officials:
affiliation: University Hospital of Lille
name: François PATTOU, Professor
role: PRINCIPAL_INVESTIGATOR
References: