The purpose of this research study is to learn more about the use of the Fractyl Revita System for the treatment of type 2 diabetes in patients who are on insulin therapy and certain other diabetes medications. The Revita System is a device that aids in removing excess tissue from the inner most layer of the small intestine, which is believed to play an important role in the control of type 2 diabetes. The procedure is expected to lead to an improvement in blood sugar control.
At the first visit, we will ask you to complete forms, questionnaires, undergo a physical exam, body measurements, and blood work. Visit 2 will include a medication review. Visit 3 will include an ECG, urine tests and imaging procedures to assess the health of your liver. Visit 4 you will undergo the duodenal mucosal resurfacing procedure. Following the procedure, you will be asked to follow a special diet for 14 days. From Day 15 following your procedure to the End of Study, you will be asked to check your blood glucose at least 2 times (fasting and before dinner).
Endocrinology Outpatient Center
UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA
Nicholas Shaheen
Medicine-Endocrinology
Clinical or Medical
Interventional
Diabetes
Eating, Nutrition, and Metabolism
Wellness and Lifestyle
UNC or UNC Health employees
23-0413