Safety And Efficacy Of EndoBarrier In Subjects With Type 2 Diabetes Who Are Obese
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-007710
- Scottsdale/Phoenix, Arizona: 12-007710
NCT ID: NCT01728116
Sponsor Protocol Number: 09-1
About this study
To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Study closed to enrollment
Inclusion Criteria:
- HbA1c ≥ 7.5% and ≤ 10%
- BMI ≥ 30 and ≤ 55
Exclusion Criteria:
- Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
- C-peptide < 1.0 ng/mL
- Previous GI surgery or abnormal GI anatomical finding
- Prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent)
- Symptomatic kidney stones or any biliary disease within 6 months prior to randomization
- Known hepatic disease (e.g. viral, autoimmune, fibrosis/cirrhosis etiology but not including incidental fatty liver
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Adrian Vella, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator John DiBaise, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available