Endobarrier Treatment in Obese Subjects With T2DM

NCT01718457 | Unknown Phase 4

• 1 other identifier: SHEBA-12-9626-GL-CTIL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Obesity

Keywords

Endobarrier; Diabetes; Obesity; Weight; BMI; Lipid profile; fatty liver; gut peptides; HbA1c

Outcome Measures

Primary Outcomes (2)

• percent change in HbA1c level

  1 year, 2 years

• percent change in BMI

  1 year, 2 years

Secondary Outcomes (5)

• percent change in LDL cholesterol levels

  1 year, 2 years

• change in waist circumference

  1 year, 2 years

• change in fasting plasma glucose level

  1 year, 2 years

• percent change in HDL cholesterol levels

  1 year, 2 year

• percent in Triglycerides levels

  1 year, 2 years

Other Outcomes (4)

• change in degree of fatty liver

  1 year, 2 years

• change in plasma gut peptide levels

  1 year, 2 years

• change in plasma insulin level

  1 year, 2 years

Study Arms (1)

Endobarrier device insertion

EXPERIMENTAL

Device: Endobarrier

Interventions

Endobarrier DEVICE

Also known as: Duodenal-Jejunal Bypass Liner

Endobarrier device insertion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects taking systemic corticosteroids or drugs known to affect GI motility within 30 days prior to randomization
• Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to randomization (including GLP-1 analogs).
• Previous GI surgery that could preclude the ability to place the EndoBarrier device, liner or affect the function of the implant
• 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
• Subjects with active GERD not taking a Proton Pump Inhibitor (PPI)
• Subjects with symptomatic kidney stones within 6 months prior to randomization.
• Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, atresias or stenoses, upper gastro-intestinal bleeding conditions
• Subjects with symptomatic gallstones within 6 months prior to randomization
• Coagulopathy defined as hgb \<10g/dl and platelet \< 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities
• Any documented history of acute or chronic pancreatitis
• Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent)
• 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
• Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
• Subject is or has been enrolled in another investigational study within 3 months of participation into the EndoBarrier study
• Subjects with poor dentition who cannot completely chew their food.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center, Tel-Hashomer

Ramat Gan, 52621, Israel

Location

Related Publications (1)

• de Moura EG, Martins BC, Lopes GS, Orso IR, de Oliveira SL, Galvao Neto MP, Santo MA, Sakai P, Ramos AC, Garrido Junior AB, Mancini MC, Halpern A, Cecconello I. Metabolic improvements in obese type 2 diabetes subjects implanted for 1 year with an endoscopically deployed duodenal-jejunal bypass liner. Diabetes Technol Ther. 2012 Feb;14(2):183-9. doi: 10.1089/dia.2011.0152. Epub 2011 Sep 20.

  PMID: 21932999 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Diabetes Mellitus; Body Weight; Fatty Liver

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Gabriella Segal-Lieberman, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2018
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

IL (1)