ENDOBARRIER® and Conventional Therapy in the Management of Metabolic Syndrome in Obese Patients (ENDOMETAB)

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.

Study Overview

• Status: Terminated
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Device: ENDOBARRIER®

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bobigny, France
    • Hopital Avicenne
  • Boulogne Billancourt, France
    • Hôpital Ambroise Paré (AP-HP)
  • Colombes, France
    • Hopital Louis Mourier
  • Lille, France, 59000
    • University Hospital Lille
  • Lyon, France
    • Hospice civils de Lyon
  • Marseille, France
    • Assistance Publique Des Hopitaux de Marseille
  • Montpellier, France
    • Centre Hospitalier Universitaire
  • Nantes, France
    • Centre Hospitalier Universitaire
  • Strasbourg, France
    • Nouvel Hôpital Civil
  • Toulouse, France
    • Hopital Larrey- Chu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional medical therapy; Conventional medical therapy is defined as the use of the latest lifestyle guidelines to optimize weight loss and glycaemic management, frequent home monitoring/titration strategies, use of latest approved drug therapy for treatment of hyperglycaemia and restoration of pancreatic B cell function, also for dyslipidemia and hypertension in addition to regular follow-up visits to a medical doctor from a multidisciplinary team
Experimental: ENDOBARRIER®; The interventional therapy will be the device ENDOBARRIER® over conventional medical therapy	Device: ENDOBARRIER®; This medical device consists of a tube (impermeable fluoropolymer) inserted endoscopically and secured by hooks in the wall of the duodenal bulb. From the anchor site, this duodeno-jejunal sheath covers 60 cm in the small intestine. It thus limits the contact of nutrients with digestive juices (bile and pancreatic juice) and initial absorption, at least in part mimicking duodenal exclusion of the gastric bypass, one of the techniques of bariatric surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of patients without Metabolic Syndrome	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.	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of insulin resistance		12 months, 24 months
Changed in cardiovascular risk assessed by Framingham Risk Score		12 months, 24 months
Changed in quality of life		12 months, 24 months
Rate of adverse events		12 months, 24 months
The cost-benefit ratio for each group	The cost-benefit ratio for each group by evaluating the medical costs in each arm	12 months, 24 months
Changed in blood pressure	Changed in specific metabolic syndrome parameters such blood pressure	12 months, 24 months
Changed in blood sugar	Changed in blood sugar	12 months, 24 months
Changed in triglycerides	Changed in triglycerides	12 months, 24 months
Changed in HDL	Changed in HDL	12 months, 24 months
Changed in waist circumference	Changed in waist circumference	12 months, 24 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: François PATTOU, Professor, University Hospital of Lille

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: November 20, 2014
• First Posted (Estimate): November 21, 2014

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Metabolic Syndrome; ENDOBARRIER®
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 2013_26; 2013-A00980-45 (Other Identifier: ID-RCB number, ANSM); STIC 2012 (Other Identifier: STIC number, Ministry of Health France)