Status:
COMPLETED
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
Lead Sponsor:
Morphic Medical Inc.
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- Age 18 to 65
- BMI 40 to 60
- Type II Diabetes
- Candidates for bariatric surgery
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00791128
Start Date
October 1 2008
End Date
December 1 2010
Last Update
June 1 2017
Active Locations (1)
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1
Dr. Eduardo Guimaraes Hourneauz de Moura
São Paulo, São Paulo, Brazil, 05493900