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Endobarrier Treatment in Obese Subjects With T2DM

This study is not yet open for participant recruitment.
Verified November 2012 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01718457
First received: October 29, 2012
Last updated: November 6, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes
Obesity
 Device: Endobarrier
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endobarrier Treatment in Obese Subjects With T2DM

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • percent change in HbA1c level [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • percent change in BMI [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • percent change in LDL cholesterol levels [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • change in waist circumference [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • change in fasting plasma glucose level [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • percent change in HDL cholesterol levels [ Time Frame: 1 year, 2 year ] [ Designated as safety issue: No ]
  • percent in Triglycerides levels [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • change in degree of fatty liver [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
    liver enzymes, liver ultrasound, fibromax tests

  • change in plasma gut peptide levels [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
    GLP-1, PYY, Oxynthomodulin, Ghrelin

  • change in plasma insulin level [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]
  • change in C-peptide levels [ Time Frame: 1 year, 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: December 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endobarrier device insertion Device: Endobarrier
Other Name: Duodenal-Jejunal Bypass Liner

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718457

Contacts
Contact: Gabriella Segal-Lieberman, MD 972-526666778 gabriella.lieberman@sheba.health.gov.il
Contact: Ayana Paster, RD 972-528219972 endo.r@sheba.health.gov.il

Locations
Israel
Sheba medical center, Tel-Hashomer Not yet recruiting
Ramat-Gan, Israel, 52621
Contact: Gabriella Segal-Lieberman, MD     972-526666778     gabriella.lieberman@sheba.health.gov.il    
Sub-Investigator: Alon Lang, MD            
Sub-Investigator: Maor Lahav, MD            
Sub-Investigator: Ohad Cohen, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Gabriella Segal-Lieberman, MD Sheba Medical Center
  More Information

Publications:

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01718457     History of Changes
Other Study ID Numbers: SHEBA-12-9626-GL-CTIL
Study First Received: October 29, 2012
Last Updated: November 6, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Sheba Medical Center:
Endobarrier
Diabetes
Obesity
Weight
BMI
 Lipid profile
fatty liver
gut peptides
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013