AN INVESTIGATIONAL PROCEDURE MAY HELP MANAGE TYPE 2 DIABETES WITHOUT INCREASING MEDICATIONS
Find out if you qualify for a non-drug clinical research study.
If you’re living with type 2 diabetes (T2D), you may have experienced challenges in lowering blood sugar levels, despite taking medications and making lifestyle changes. That’s why we’re studying a new, non-drug procedure that may change how T2D is treated in the future.
The Revitalize 1 clinical study
The Revitalize 1 clinical study is evaluating an endoscopic procedure for T2D that may improve blood sugar. Revita® aims to target the underlying cause of T2D and slow the progression of the disease and its health complications. All eligible patients can receive the procedure and medical care related to the study at no cost.
You may be eligible for the Revitalize 1 clinical study if you:
- Have been diagnosed with type 2 diabetes
- Have a body mass index (BMI) >24 to ≤ 40
- Are between the ages of 21-70
- Are taking medications for type 2 diabetes
- Have an A1c between 7.5-10% (9.4-13.4 mmol/L)
What to Expect
The Revitalize 1 clinical study has 3 stages:
Screening Period
(up to 6 weeks)
This will include 3 study visits at the study center or your home. It is during this period that it is 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 at the study center 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.
Next Steps
To participate in the T2 diabetes study, you will need to:
- Fill out the eligibility questionnaire above
- Receive a call from the study staff to answer further qualifications questions and schedule your first screening visit
- If you meet the basic qualifications, your next steps are the screening and preparation period which will take 6-7 weeks. During this time, it will be determined if the study is right for you and you may be asked to complete Release of Medical Records form.
- Participants that move on to the next step are randomized and then receive either the Revita or sham procedure. The follow-up period is 48 weeks. After the follow-up period, all participants that had the sham procedure will be offered the Revita procedure if they are willing, and it is clinically beneficial to them and will have an additional 48-week follow-up period.
What is the procedure?
Revita® is a non-surgical procedure that targets a portion of the small intestine called the duodenum to help control blood sugar levels. Studies have shown that treating the duodenum can improve type 2 diabetes.1,2,3 Patients are asleep during the procedure, which lasts about one hour and following the procedure you will be closely monitored in the recovery room. You may resume normal activities after being discharged from the hospital.
Frequently Asked Questions
What is the goal of this study?
Revitalize 1 is a clinical research study evaluating an exciting novel procedure for type 2 diabetes that may improve blood sugar without increasing insulin or other medications. All eligible patients can receive the Revita procedure and medical care related to the study at no cost.
What is a sham procedure?
Similar to how a medication study uses a placebo (sugar pill) for comparison, sham procedures are used in clinical study so that results of the sham procedures can be compared with the results of the study procedure. Having a comparison allows for a clearer understanding of the procedure results.
In the case of this clinical study, those receiving the sham procedure would undergo many of the steps of the Revita procedure but without the heating process used to remove the excess layer of the duodenum. But don’t worry! If you end up in the group receiving the sham procedure and are still considered eligible, you will be offered the opportunity to receive the Revita procedure later in the study!
Is there compensation for my participation?
Yes. Participants may receive compensation for their participation which varies depending on location and more details on compensation may be provided by the study site. If you enrolled in the sham arm of the study which lasts up to 2 years you will receive additional compensation than patients enrolled in the treatment arm who are enrolled in the study for up to 1 year.
Will the study cost anything?
No. All study-related activities and procedure will be provided at no cost. Transportation support is also available if assistance is needed for getting to and from study visits.
1. van Baar et al. Gut. 2020; 69(2):295-303
2. van Baar et al. Diabetes Res Clin Pract. 2022;12:109194
3. Mingrone et al. Gut. 2022; 71(2):254-264