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

GI Dynamics

Status and phase: Completed; Phase 2

Conditions: Obesity; Type 2 Diabetes

Treatments: Device: GI Liner

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791128

06-6

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

EndoBarrier GI Liner

Experimental group

Description:

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

Treatment:

Device: GI Liner