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Metabolic SyndromeENDOMETABNCT02297555

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

A study testing ENDOBARRIER® in people with Metabolic Syndrome, run by University Hospital, Lille at 10 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
ENDOBARRIER®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
10 sitesFrance
Study dates
Apr 2014to Oct 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Contraindications from the notice of ENDOBARRIER device

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

France10 sites

  • Hôpital Avicenne

    Bobigny

  • Hopital Ambroise Pare (Ap-Hp)

    Boulogne-Billancourt

  • Hopital Louis Mourier

    Colombes

  • University Hospital Lille

    Lille, 59000

  • Hospice civils de Lyon

    Lyon

  • Assistance Publique des Hôpitaux de Marseille

    Marseille

  • Centre Hospitalier Universitaire

    Montpellier

  • Centre Hospitalier Universitaire

    Nantes

  • Nouvel Hôpital Civil

    Strasbourg

  • Hopital Larrey- Chu

    Toulouse

Other trials in France

About this study

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.

Read the 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.

Being tested
ENDOBARRIER®
Keywords
Obesity, Metabolic Syndrome, ENDOBARRIER®
Medical subject headings
Metabolic Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02297555
Study groupRoleWhat they receive
Conventional medical therapyNo interventionConventional 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®ExperimentalThe interventional therapy will be the device ENDOBARRIER® over conventional medical therapy
Receives: Device: ENDOBARRIER®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 month

Secondary outcomes (10)

  1. The level of insulin resistance

    Measured: 12 months, 24 months

  2. Changed in cardiovascular risk assessed by Framingham Risk Score

    Measured: 12 months, 24 months

  3. Changed in quality of life

    Measured: 12 months, 24 months

  4. Rate of adverse events

    Measured: 12 months, 24 months

  5. The cost-benefit ratio for each group

    The cost-benefit ratio for each group by evaluating the medical costs in each arm

    Measured: 12 months, 24 months

  6. Changed in blood pressure

    Changed in specific metabolic syndrome parameters such blood pressure

    Measured: 12 months, 24 months

  7. Changed in blood sugar

    Changed in blood sugar

    Measured: 12 months, 24 months

  8. Changed in triglycerides

    Changed in triglycerides

    Measured: 12 months, 24 months

  9. Changed in HDL

    Changed in HDL

    Measured: 12 months, 24 months

  10. Changed in waist circumference

    Changed in waist circumference

    Measured: 12 months, 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJan 2017
  4. Study completionOct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02297555
Sponsor's protocol ID
2013_26
Other IDs
2013-A00980-45, STIC 2012
Acronym
ENDOMETAB
Status last verified
May 2018
First submitted
18 Sep 2014
Last updated
18 May 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ENDOBARRIER® in people with Metabolic Syndrome, run by University Hospital, Lille at 10 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of patients without Metabolic Syndrome (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02297555.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.

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