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

Phase 2

Completed

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Device: GI Liner

• Registration Number: NCT00791128
• Lead Sponsor: Morphic Medical Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-11-12
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Primary Completion: 2010-03
• Study Completion: 2010-12
• Results First Submitted: 2016-11-01
• Results First Submitted QC: 2016-11-01
• Results First Posted: 2016-12-28
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EndoBarrier GI Liner	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.

Primary Outcome Measures

Name	Time	Method
% of Excess Weight Loss (EWL)	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

Secondary Outcome Measures

Name	Time	Method
HbA1c Values at 12 Months	12 months

Trial Locations

Locations (1)

Dr. Eduardo Guimaraes Hourneauz de Moura; 🇧🇷 Sao Paulo, SP, Brazil