Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
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ClinicalTrials.gov Identifier: NCT00791128 |
Recruitment Status :
Completed
First Posted : November 14, 2008
Results First Posted : December 28, 2016
Last Update Posted : June 1, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes Obesity | Device: GI Liner | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2008 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | December 2010 |

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.
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Device: GI Liner
Medical device placed endoscopically in the duodenum, nutritional counseling
Other Name: GI Endobarrier Liner |
- % 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
- HbA1c Values at 12 Months [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791128
Brazil | |
Dr. Eduardo Guimaraes Hourneauz de Moura | |
Sao Paulo, SP, Brazil, 05493900 |
Principal Investigator: | Eduardo Guimaraes Hourneaux de Moura, MD | Hospital das Clinicas, Sao Paulo |
Responsible Party: | GI Dynamics |
ClinicalTrials.gov Identifier: | NCT00791128 |
Other Study ID Numbers: |
06-6 |
First Posted: | November 14, 2008 Key Record Dates |
Results First Posted: | December 28, 2016 |
Last Update Posted: | June 1, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Type 2 Diabetes |
Diabetes Mellitus Diabetes Mellitus, Type 2 Weight Loss Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Body Weight Changes Body Weight |