Join Trial Testing ReCET Therapy for Type 2 Diabetes
Researchers are studying an endoscopic intestinal (ReCET) therapy that treats the lining of the upper small intestine to see if it improves blood sugar management in individuals with type 2 diabetes.
Trial status: Recruiting
Clinical Trials Identifier: NCT06267391
Trial Name: Safety and Effectiveness of Endoscopic Intestinal Re-Cellularization Therapy in Individuals With Type 2 Diabetes (ReCET)
Diabetes Type: Type 2 diabetes
Trial Sponsor: Endogenex, Inc.
Why is this study important?
This study is testing endoscopic intestinal re-cellularization (ReCET) therapy to see if it can help people with type 2 diabetes improve their blood sugar management. The device treats the first part of the small intestine (duodenum), which plays a role in blood sugar regulation. When the duodenum senses glucose, it releases hormones that signal the pancreas to secrete insulin. However, the cells on the inner lining of the duodenum may not work properly in people with type 2 diabetes.
The ReCET treatment involves placing a thin tube with a camera into the mouth and down to the small intestine. It then uses electrical pulses to remove cells in the intestine lining, which are replaced with new, healthy cells – almost like hitting the “reset” button on that part of the gut. Previous studies have shown that individuals on Ozempic who tried ReCET therapy saw improvements in A1C levels, fasting glucose, and percent liver fat.
A similar procedure known as duodenal mucosal resurfacing (DMR) also removes cells in the intestinal lining, but uses heat instead of electrical pulses.
How does the trial work?
Participants will be randomly assigned to the treatment group or the placebo group. Those assigned to a treatment group will receive the ReCET therapy, where a thin tube is passed through the mouth to deliver electrical pulses to the upper small intestine. The placebo group will also have the tube placed, as described above, but without any therapy applied to the small intestine. Both groups will be followed for one year after the procedure.
To determine the safety and effectiveness of ReCET therapy, researchers will measure changes to A1C at months six and 12, along with changes in time in range and body weight.
Are you interested in participating?
You may be eligible to participate if you are 22-70 years of age and have:
- Been diagnosed with type 2 diabetes for at least six months
- An A1C of 7.5-10.5%
- A BMI of 27-40
- Been on two to four non-insulin, glucose-lowering medications or on monotherapy with either GLP-1 or GLP-1/GIP medications, with no changes in medication or dosing for at least 12 weeks prior to the baseline visit.
People who have type 1 diabetes or a history of diabetic ketoacidosis are not eligible to participate in this study. See a full list of inclusion/exclusion criteria here. This trial is currently recruiting in multiple states across the U.S. and in Australia.
Learn more about emerging treatments for type 2 diabetes here: