Are you living with type 2 diabetes?
The ReCET study is a clinical research study evaluating if the non-surgical ReCET™ procedure can help lower or better control blood sugar levels in people with type 2 diabetes.
Who can join?
The study needs volunteers who meet these requirements:*
- 22 to 70 years of age
- diagnosed with type 2 diabetes (at least 6 months ago)
- taking 2 to 4 blood sugar controlling medications
- not using insulin.
* Other requirements apply.
Apply to participate in this study
What is the ReCET™ procedure?
The ReCET procedure is an investigational procedure, which means it is only approved for use in the ReCET study.
The procedure is designed to renew the lining of the first part of the small intestine, called the duodenum. The duodenum helps manage blood sugar levels; renewing its lining may improve blood sugar control.
What does the procedure involve?
While the participant is asleep, the study doctor does the procedure through the mouth, using a small camera. This is called an endoscopic procedure. The doctor guides a thin tube (called a catheter) to the small intestine. There, the catheter delivers controlled electric energy to the intestinal lining. The electric energy causes unhealthy cells to die and be replaced by new, healthy cells that may help better control blood sugar levels.
After the procedure, the device and the camera are removed, and nothing is left inside the body. Participants are observed in the recovery room and can go home the same day.
What can study participants expect?
The ReCET study lasts about 1 year and has 4 main parts (listed below). There is no cost for care provided as part of the study. Participants receive a stipend (or reimbursement) for expenses related to the study.
Screening:
- Study health checks to find out if you qualify.
Pre-procedure visit:
- Study health checks to record your health status.
- Diabetes education.
- Glucose (blood sugar) monitoring instruction.
Study procedure:♦
- Same-day procedure.
- Normal activities the next day.
- Modified diet for the next 2 weeks.
Follow-up visits:
- Combination of clinic visits and phone visits.
- Visits at 1 and 2 weeks after the study procedure, then monthly visits for study health checks and diabetes education.
- Daily glucose (blood sugar) monitoring (does not require visits).
♦ Some participants (assigned at random) will have the ReCET procedure, and others will have a control procedure instead. The control procedure is similar to the ReCET procedure but without energy delivery. Participants who receive the control procedure will have the opportunity to receive the ReCET procedure after they complete the main study.
Apply to participate in this study
If you are interested in participating or would like further information, please contact:
Yas Elghattis
Clinical Research Coordinator
T: 0411 737 441
E: yasser.elghattis@baker.edu.au
More information
What is type 2 diabetes?
Type 2 diabetes is a progressive disease that causes high blood sugar levels. Over time, too much sugar in the blood can damage blood vessels, kidneys, eyes and other parts of the body.
Research has shown that cells in a portion of the small intestine, called the duodenum, play an important role in managing blood sugar levels. In people with type 2 diabetes, the cells in the duodenum may not work correctly.
The investigational procedure used in the ReCET study is designed to help the body make new cells in the duodenum. These new cells may help the body better manage blood sugar levels.