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Endobarrier Treatment in Obese Subjects With T2DM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01718457
Recruitment Status : Unknown
Verified June 2014 by Sheba Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : October 31, 2012
Last Update Posted : July 1, 2014
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

Diabesity (Diabetes accompanied by obesity) is a prevalent condition many times complicated by micro- and macrovascular disease. Many treatments for Diabesity paradoxically cause further weight gain and hypoglycemia. The Endobarrier enables diabetes control along with weight loss as an alternative to bariatric surgery for patients who are not interested or not qualified for surgery. The aim of this study is to assess the efficacy and safety of the Endobarrier Diabesity patients in Israel.

This study will include 45 men and women between the ages of 18-65 with HbA1c level of 8% and above and a BMI of 30 kg/m2 or above.

Exclusion criteria: use of anti-coagulant, use of steroids or inability to discontinue these medications.

The cohort will be followed for two years during which the patients will be monitored for diabetes control (by using a continuous glucose monitor), weight, blood pressure, lipid profile, fatty liver (by Ultrasound and blood markers for inflammation and fibrosis) and change in plasma gut peptide levels. The Endobarrier will be explanted after one year, however the monitoring of the patients will continue for another year.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Device: Endobarrier Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endobarrier Treatment in Obese Subjects With T2DM
Study Start Date : December 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Endobarrier device insertion Device: Endobarrier
Other Name: Duodenal-Jejunal Bypass Liner

Primary Outcome Measures :
  1. percent change in HbA1c level [ Time Frame: 1 year, 2 years ]
  2. percent change in BMI [ Time Frame: 1 year, 2 years ]

Secondary Outcome Measures :
  1. percent change in LDL cholesterol levels [ Time Frame: 1 year, 2 years ]
  2. change in waist circumference [ Time Frame: 1 year, 2 years ]
  3. change in fasting plasma glucose level [ Time Frame: 1 year, 2 years ]
  4. percent change in HDL cholesterol levels [ Time Frame: 1 year, 2 year ]
  5. percent in Triglycerides levels [ Time Frame: 1 year, 2 years ]

Other Outcome Measures:
  1. change in degree of fatty liver [ Time Frame: 1 year, 2 years ]
    liver enzymes, liver ultrasound, fibromax tests

  2. change in plasma gut peptide levels [ Time Frame: 1 year, 2 years ]
    GLP-1, PYY, Oxynthomodulin, Ghrelin

  3. change in plasma insulin level [ Time Frame: 1 year, 2 years ]
  4. change in C-peptide levels [ Time Frame: 1 year, 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subjects willing to comply with study requirements and have signed an informed consent form.
  2. Age 18-65
  3. BMI ≥ 30 kg/m²
  4. HbA1c% as assessed by central laboratory ≥ 8.0%.
  5. Documented negative pregnancy test in women of childbearing potential.
  6. Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.

Exclusion Criteria:

  1. Subjects taking systemic corticosteroids or drugs known to affect GI motility within 30 days prior to randomization
  2. Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to randomization (including GLP-1 analogs).
  3. Previous GI surgery that could preclude the ability to place the EndoBarrier device, liner or affect the function of the implant
  4. Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the Investigator, may impair implantation of the EndoBarrier device
  5. Subjects with active GERD not taking a Proton Pump Inhibitor (PPI)
  6. Subjects with symptomatic kidney stones within 6 months prior to randomization.
  7. Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, atresias or stenoses, upper gastro-intestinal bleeding conditions
  8. Subjects with symptomatic gallstones within 6 months prior to randomization
  9. Coagulopathy defined as hgb <10g/dl and platelet < 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities
  10. Any documented history of acute or chronic pancreatitis
  11. Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent)
  12. Subjects unable to discontinue Aspirin or any other NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect (i.e coumadin) during the study duration
  13. Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
  14. Subject is or has been enrolled in another investigational study within 3 months of participation into the EndoBarrier study
  15. Subjects with poor dentition who cannot completely chew their food.
  16. Subjects with thyroid disease unless controlled with a therapeutic dose of medication and have normal thyroid function tests for a minimum of 6 months prior to randomization
  17. Subjects not residing within a 3 hour driving distance of the study center.
  18. Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study
  19. Subjects with known allergies or hypersensitivity to ceftrixone, cephalosporins or penicillin


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01718457

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Sheba medical center, Tel-Hashomer
Ramat-Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
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Principal Investigator: Gabriella Segal-Lieberman, MD Sheba Medical Center

Publications of Results:
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Responsible Party: Sheba Medical Center Identifier: NCT01718457    
Other Study ID Numbers: SHEBA-12-9626-GL-CTIL
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014
Keywords provided by Sheba Medical Center:
Lipid profile
fatty liver
gut peptides
Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms