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

Primary Purpose

Type 2 Diabetes, Obesity

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
GI Liner
Sponsored by
GI Dynamics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Eduardo Guimaraes Hourneauz de Moura

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EndoBarrier GI Liner

Arm Description

22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period.

Outcomes

Primary Outcome Measures

% of Excess Weight Loss (EWL)
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

Secondary Outcome Measures

HbA1c Values at 12 Months

Full Information

First Posted
November 12, 2008
Last Updated
April 12, 2017
Sponsor
GI Dynamics
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1. Study Identification

Unique Protocol Identification Number
NCT00791128
Brief Title
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EndoBarrier GI Liner
Arm Type
Experimental
Arm Description
22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period.
Intervention Type
Device
Intervention Name(s)
GI Liner
Other Intervention Name(s)
GI Endobarrier Liner
Intervention Description
Medical device placed endoscopically in the duodenum, nutritional counseling
Primary Outcome Measure Information:
Title
% of Excess Weight Loss (EWL)
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HbA1c Values at 12 Months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Guimaraes Hourneaux de Moura, MD
Organizational Affiliation
Hospital das Clinicas, Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Eduardo Guimaraes Hourneauz de Moura
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05493900
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21932999
Citation
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.
Results Reference
result

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

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