Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese

Overview

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

Adrian Vella, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20118616

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