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

Metabolic Syndrome Clinical Trial

— ENDOMETAB  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02297555
• Other study ID #: 2013_26
• Secondary ID: 2013-A00980-45ST
• Status: Terminated
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: October 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Avicenne	Bobigny
France	Hopital Ambroise Pare (Ap-Hp)	Boulogne Billancourt
France	Hopital Louis Mourier	Colombes
France	University Hospital Lille	Lille
France	Hospice civils de Lyon	Lyon
France	Assistance Publique des Hôpitaux de Marseille	Marseille
France	Centre Hospitalier Universitaire	Montpellier
France	Centre Hospitalier Universitaire	Nantes
France	Nouvel Hôpital Civil	Strasbourg
France	Hopital Larrey- Chu	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The level of insulin resistance		12 months, 24 months
Secondary	Changed in cardiovascular risk assessed by Framingham Risk Score		12 months, 24 months
Secondary	Changed in quality of life		12 months, 24 months
Secondary	Rate of adverse events		12 months, 24 months
Secondary	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
Secondary	Changed in blood pressure	Changed in specific metabolic syndrome parameters such blood pressure	12 months, 24 months
Secondary	Changed in blood sugar	Changed in blood sugar	12 months, 24 months
Secondary	Changed in triglycerides	Changed in triglycerides	12 months, 24 months
Secondary	Changed in HDL	Changed in HDL	12 months, 24 months
Secondary	Changed in waist circumference	Changed in waist circumference	12 months, 24 months