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

November 1, 2016 updated by: GI Dynamics

A Pilot Feasibility Sham Controlled Study of the GI Sleeve for the Treatment of Type 2 Diabetes

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EndoBarrier Gastrointestinal Liner
Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.
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.
Other Names:
  • GI Sleeve
Experimental: Sham: endoscopy and standard of care
Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.
Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c Values From Baseline Measurement
Time Frame: Baseline to 24 weeks or 52 weeks

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.

Baseline to 24 weeks or 52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Absolute Weight Change
Time Frame: 24 weeks or 52 weeks
24 weeks or 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Leonardo Rodriguez Grunert, MD, Hospital Dipreca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

December 28, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes

Clinical Trials on EndoBarrier Gastrointestinal Liner

3
Subscribe