NCT02297555

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

September 18, 2014

Last Update Submit

May 15, 2018

Conditions

Metabolic Syndrome

Keywords

ObesityMetabolic SyndromeENDOBARRIER®

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

    12 months, 24 months

  • +5 more secondary outcomes

Study Arms (2)

Conventional medical therapy

NO INTERVENTION

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

ENDOBARRIER®

EXPERIMENTAL

The interventional therapy will be the device ENDOBARRIER® over conventional medical therapy

Device: ENDOBARRIER®

Interventions

ENDOBARRIER®DEVICE

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.

ENDOBARRIER®

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications from the notice of ENDOBARRIER device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hôpital Avicenne

Bobigny, France

Location

Hopital Ambroise Pare (Ap-Hp)

Boulogne-Billancourt, France

Location

Hopital Louis Mourier

Colombes, France

Location

University Hospital Lille

Lille, 59000, France

Location

Hospice civils de Lyon

Lyon, France

Location

Assistance Publique des Hôpitaux de Marseille

Marseille, France

Location

Centre Hospitalier Universitaire

Montpellier, France

Location

Centre Hospitalier Universitaire

Nantes, France

Location

Nouvel Hôpital Civil

Strasbourg, France

Location

Hopital Larrey- Chu

Toulouse, France

Location

MeSH Terms

Conditions

Metabolic SyndromeObesity

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • François PATTOU, Professor

    University Hospital of Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2014

First Posted

November 21, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2017

Study Completion

October 1, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Locations

FR(10)