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A Study of the GI Sleeve for the Treatment of Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
EndoBarrier Gastrointestinal Liner
Sham: endoscopy and standard of care
Sponsored by
GI Dynamics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 years and < 55 years - Male or Female
  • Patients with type 2 diabetes, treated for 10 years or less
  • HbA1c level ≥ 7.0 and ≤ 10.0%
  • Fasting glucose ≤ 240 mg/dl
  • Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination
  • BMI > 30 and <50
  • Patients willing to comply with study requirements
  • Patients who have signed an informed consent form
  • Women who are post-menopausal, surgically sterile, or on oral contraceptives for at least three months and who do not plan on becoming pregnant during the course of the study.

Exclusion Criteria:

  • Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones
  • Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis
  • Patients requiring insulin
  • Patients with lab evidence of probable insulin production failure (fasting C peptide serum level < 1ng/ml)
  • Patients with a weight loss of > 10 lbs within the three months of screening
  • Patients requiring prescription anticoagulation therapy
  • Patients with iron deficiency and iron deficiency anemia
  • Patients with a history of abnormal pathologies of the GI tract
  • Patients with known gallstones or kidney stones prior to implant
  • Known infection at the time of implant
  • Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
  • Pregnant or has the intention of becoming pregnant in the next 12 months
  • Patients with a history of active kidney stones
  • Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial
  • Previous GI surgery that could affect the ability to place the sleeve or the function of the implant
  • Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
  • H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated)
  • Patients receiving weight loss medications such as Meridia and Xenical
  • Family or patient history of a known diagnosis or pre-existing symptom of systemic lupus erythematous, scleroderma or other autoimmune connective tissue disorder
  • Patients with Gastrointestinal Reflux Disease (GERD)
  • Participating in another ongoing investigational clinical trial
  • Patients taking corticosteroids or drugs known to affect gastrointestinal motility (such as reglan)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    EndoBarrier Gastrointestinal Liner

    Sham: endoscopy and standard of care

    Arm Description

    Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.

    Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.

    Outcomes

    Primary Outcome Measures

    Change in HbA1c Values From Baseline Measurement
    Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline. Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.

    Secondary Outcome Measures

    Absolute Weight Change

    Full Information

    First Posted
    March 11, 2016
    Last Updated
    November 1, 2016
    Sponsor
    GI Dynamics
    Collaborators
    Hospital Dipreca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02709577
    Brief Title
    A Study of the GI Sleeve for the Treatment of Type 2 Diabetes
    Official Title
    A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2007 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GI Dynamics
    Collaborators
    Hospital Dipreca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study was to evaluate the safety and efficacy of the EndoBarrier Gastrointestinal Liner compared to sham control in subjects with Type 2 diabetes.
    Detailed Description
    The study was designed as a randomized, single blind, sham controlled, pilot efficacy study of subjects with Type 2 diabetes enrolled at 2 centers in Santiago, Chile. Subjects were enrolled at a 2:1 ratio (EndoBarrier to sham). Following implantation or sham procedure, subjects were treated for 24 weeks or 52 weeks. Following explant, subjects were followed for an additional 8-12 weeks. Subject evaluations included measurements of HbA1c, glucose, insulin, weight, changes in diabetic medications, and meal tolerance tests. Safety was monitored through the collection of clinical labs, physical assessments, endoscopy and adverse events.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EndoBarrier Gastrointestinal Liner
    Arm Type
    Experimental
    Arm Description
    Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.
    Arm Title
    Sham: endoscopy and standard of care
    Arm Type
    Experimental
    Arm Description
    Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.
    Intervention Type
    Device
    Intervention Name(s)
    EndoBarrier Gastrointestinal Liner
    Other Intervention Name(s)
    GI Sleeve
    Intervention Description
    The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.
    Intervention Type
    Other
    Intervention Name(s)
    Sham: endoscopy and standard of care
    Other Intervention Name(s)
    Control
    Intervention Description
    Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes
    Primary Outcome Measure Information:
    Title
    Change in HbA1c Values From Baseline Measurement
    Description
    Cohort A: Assessment of improvement in the glycemic control defined as a change in HbA1c values from baseline. Cohort B. Assessment of improvement in glycemic control defined as a change in HbA1c values of at least 0.5% from baseline.
    Time Frame
    Baseline to 24 weeks or 52 weeks
    Secondary Outcome Measure Information:
    Title
    Absolute Weight Change
    Time Frame
    24 weeks or 52 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age > 18 years and < 55 years - Male or Female Patients with type 2 diabetes, treated for 10 years or less HbA1c level ≥ 7.0 and ≤ 10.0% Fasting glucose ≤ 240 mg/dl Patients taking metformin, sulfonylureas or thiazolidinediones (TZDs), either alone or in combination BMI > 30 and <50 Patients willing to comply with study requirements Patients who have signed an informed consent form Women who are post-menopausal, surgically sterile, or on oral contraceptives for at least three months and who do not plan on becoming pregnant during the course of the study. Exclusion Criteria: Patients taking oral medications to control their diabetes other than sulfonylureas, metformin or thiazolidinediones Patients diagnosed with type 1 diabetes mellitus or had a history of ketoacidosis Patients requiring insulin Patients with lab evidence of probable insulin production failure (fasting C peptide serum level < 1ng/ml) Patients with a weight loss of > 10 lbs within the three months of screening Patients requiring prescription anticoagulation therapy Patients with iron deficiency and iron deficiency anemia Patients with a history of abnormal pathologies of the GI tract Patients with known gallstones or kidney stones prior to implant Known infection at the time of implant Severe coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia Pregnant or has the intention of becoming pregnant in the next 12 months Patients with a history of active kidney stones Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator, makes the subject a poor candidate for device placement or clinical trial Previous GI surgery that could affect the ability to place the sleeve or the function of the implant Patients unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period H. pylori positive patients (Note: patients may be enrolled if they had a prior history and were successfully treated) Patients receiving weight loss medications such as Meridia and Xenical Family or patient history of a known diagnosis or pre-existing symptom of systemic lupus erythematous, scleroderma or other autoimmune connective tissue disorder Patients with Gastrointestinal Reflux Disease (GERD) Participating in another ongoing investigational clinical trial Patients taking corticosteroids or drugs known to affect gastrointestinal motility (such as reglan)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leonardo Rodriguez Grunert, MD
    Organizational Affiliation
    Hospital Dipreca
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    A Study of the GI Sleeve for the Treatment of Type 2 Diabetes

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