Metabolic Syndrome Clinical Trial
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
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.
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.
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