The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.
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' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods. EndoBarrier 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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.
Imperial College/St. Mary's Hospital
London, United Kingdom
Trafford General Hospital/NOSC
Manchester, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
HbA1c (%) Measured at Week 52
Time frame: 12 months
Total Weight Change From Baseline to Week 52
Total weight change at 12 months (kg) compared to baseline
Time frame: 12 months
Changes in Diabetic Medications at Treatment Completion Compared to Baseline
number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)
Time frame: 12 months
Change From Baseline in SF 36v2 Quality of Life Assessment
Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI). Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject. The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.
Time frame: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)
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