ENDOBARRIER® and Conventional Therapy in the Management of Metabolic Syndrome in Obese Patients
- Conditions
- Metabolic Syndrome
- Interventions
- Device: ENDOBARRIER®
- Registration Number
- NCT02297555
- Lead Sponsor
- University Hospital, Lille
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 82
- 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
- Contraindications from the notice of ENDOBARRIER device
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ENDOBARRIER® ENDOBARRIER® The interventional therapy will be the device ENDOBARRIER® over conventional medical therapy
- Primary Outcome Measures
Name Time Method Frequency of patients without Metabolic Syndrome 12 month The primary end point will be the rate of resolution of Metabolic Syndrome at 1 year as measured by frequency of patients without MS at 12 months.
- Secondary Outcome Measures
Name Time Method Changed in waist circumference 12 months, 24 months Changed in waist circumference
The level of insulin resistance 12 months, 24 months Rate of adverse events 12 months, 24 months Changed in HDL 12 months, 24 months Changed in HDL
Changed in triglycerides 12 months, 24 months Changed in triglycerides
The cost-benefit ratio for each group 12 months, 24 months The cost-benefit ratio for each group by evaluating the medical costs in each arm
Changed in blood pressure 12 months, 24 months Changed in specific metabolic syndrome parameters such blood pressure
Changed in cardiovascular risk assessed by Framingham Risk Score 12 months, 24 months Changed in quality of life 12 months, 24 months Changed in blood sugar 12 months, 24 months Changed in blood sugar
Trial Locations
- Locations (9)
Hôpital Avicenne
🇫🇷Bobigny, France
University Hospital Lille
🇫🇷Lille, France
Hospice civils de Lyon
🇫🇷Lyon, France
Hopital Ambroise Pare (Ap-Hp)
🇫🇷Boulogne Billancourt, France
Hopital Louis Mourier
🇫🇷Colombes, France
Centre Hospitalier Universitaire
🇫🇷Nantes, France
Assistance Publique des Hôpitaux de Marseille
🇫🇷Marseille, France
Nouvel Hôpital Civil
🇫🇷Strasbourg, France
Hopital Larrey- Chu
🇫🇷Toulouse, France