Phase 2
N=22
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients
Type 2 Diabetes · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00791128 ↗Enrolled (actual)
22
Serious AEs
9.1%
Results posted
Dec 2016
Primary outcome: Primary: % of Excess Weight Loss (EWL) — 37.7 % excess weight loss
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GI Liner (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Morphic Medical Inc.
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % of Excess Weight Loss (EWL) |
37.7 | — |
| SECONDARY HbA1c Values at 12 Months |
6.6 | — |
Summary
The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00791128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.