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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Type 2 Diabetes, Obesity

Intervention / Treatment
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* Device: GI Liner


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EndoBarrier GI Liner<br>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<br>* Medical device placed endoscopically in the duodenum, nutritional counseling<br>* Other names: GI Endobarrier Liner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Values at 12 Months |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes