A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the EndoBarrier
System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and
Obesity, the STEP-1 Study.
A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and
effectiveness of the EndoBarrier System plus moderate intensity lifestyle and dietary
counseling compliant with 2019 ADA Standard of Care as compared to a sham control receiving
moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will
practice medical management compliant with STEP-1 Study Guidelines. Patients will be
randomized 3 (EndoBarrier):1 (Sham).
The objective of this study is to evaluate the safety and effectiveness of the EndoBarrier
System when used with moderate intensity lifestyle and dietary counseling and medical
management, in patients with baseline HbA1c 8.0% and 10%, and BMI 30 kg/m2 and
50kg/m2, whose diabetes medications consist of at least dual therapy for 3 months, excluding
insulin, yet have not achieved adequate HbA1c control (<7%).
Specific objectives of this study are:
To determine if the EndoBarrier System significantly improves glycemic control
To determine that the EndoBarrier System can be safely used to improve glycemic control
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.