Revitalize 1
Enrollment is paused until Summer!
Study Overview
The Revitalize 1 Study is evaluating a clinical procedure called duodenal mucosal resurfacing (DMR).
The DMR procedure called Revita® targets the lining of the duodenum and uses heat to remove the thickened or diseased lining so your body can regrow a new healthy lining capable of potentially helping you to control blood glucose, improve insulin resistance, and improve control of diabetes.
Researchers believe that the first section of your small intestine (the duodenum), located just after your stomach, has an important role in the development of type 2 diabetes. The duodenum is sensitive to the foods you eat and helps you maintain a health metabolism and blood glucose levels. However, in type 2 diabetes, the duodenum may be affected in a way that may make it hard to maintain a health metabolism and blood glucose levels.
In previous studies that evaluated DMR for the treatment of type 2 diabetes, improvements in blood glucose control and weight were seen after a single outpatient procedure.
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You may be able to take part in the Revitalize 1 study if:
Who is eligible to participate?
21-70 years of age
Have been diagnosed with type 2 diabetes
Are currently taking at least one diabetes medication
Have an HbA1c between 7.5-10%
Have a body mass index (BMI) between 24-40
Please note that this list is not extensive. If you are interested in participating, a staff member will review additional eligibility criteria with you and answer any questions you may have.
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The Remain 1 Study consists of 3 periods:
The Revitalize 1 Study consists of 3 periods:
Screening Period (up to 6 weeks)
This includes 3 study visits at the study center or your home. It is during this period that is it determined if the study is suitable for you. The study doctor may adjust your medications during this period.
Day of DMR Procedure (1 day)
You will visit the study center to have the procedure, which is expected to last approximately one hour, and go home the same day. The study team will review with you a modified diet to be followed for 14 days.
Follow-Up Period (about 1 year)
This will consist of 6 study visits and 5 phone calls. It is during this period that your progress will be monitored. The study doctor will further adjust your medications during this period.
