Study for Pre-Surgical Weight Loss in Type II Diabetes Patients

April 12, 2017 updated by: GI Dynamics

A Phase II Single-Center, Prospective, Open Label Study of Safety and Efficacy, of the GI Sleeve for Pre-Surgical Weight Loss, in Type II Diabetes Patients (Cohort 06-6B Only)

The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05493900
        • Dr. Eduardo Guimaraes Hourneauz de Moura

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 to 65
  • BMI 40 to 60
  • Type II Diabetes
  • Candidates for bariatric surgery

Exclusion Criteria:

Patients with

  • hepatitis B or C
  • gastroesophageal reflux disease (GERD)
  • HIV Positive diagnosis
  • pancreatitis
  • conditions of gastrointestinal tract, such as ulcers or Crohn's
  • an infection or who are H. Pylori positive

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EndoBarrier GI Liner
22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period.
Device: GI Liner
Medical device placed endoscopically in the duodenum, nutritional counseling
Other Names:
  • GI Endobarrier Liner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of Excess Weight Loss (EWL)
Time Frame: 12 months

Percent excess weight loss (EWL) was calculated using Body Mass Index (BMI25) method: BMI25=ideal weight in kg/(height in meters)2 Ideal weight in kg = 25 x (Height in meters2) Baseline Excess weight = total weight - ideal weight

% EWL = (baseline excess weight - weight loss) x 100
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c Values at 12 Months
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

GI Dynamics

Investigators

  • Principal Investigator: Eduardo Guimaraes Hourneaux de Moura, MD, Hospital das Clinicas, Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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