Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
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)
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes
Started Oct 2008
Typical duration for phase_2 type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 12, 2008
CompletedFirst Posted
Study publicly available on registry
November 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
December 28, 2016
CompletedJune 1, 2017
April 1, 2017
1.4 years
November 12, 2008
November 1, 2016
April 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
% 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
12 months
Secondary Outcomes (1)
HbA1c Values at 12 Months
12 months
Study Arms (1)
EndoBarrier GI Liner
EXPERIMENTAL22 patients were implanted with the GI Liner for a 52-week duration. Assessments were performed during the 6 months post-explant period.
Interventions
Medical device placed endoscopically in the duodenum, nutritional counseling
Eligibility Criteria
You may qualify if:
- Age 18 to 65
- BMI 40 to 60
- Type II Diabetes
- Candidates for bariatric surgery
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Eduardo Guimaraes Hourneauz de Moura
São Paulo, São Paulo, 05493900, Brazil
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: 21932999RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Project Manager, Clinical and Regulatory
- Organization
- GI Dynamics, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Guimaraes Hourneaux de Moura, MD
Hospital das Clinicas, Sao Paulo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2008
First Posted
November 14, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2010
Study Completion
December 1, 2010
Last Updated
June 1, 2017
Results First Posted
December 28, 2016
Record last verified: 2017-04