We are conducting a research study to explore a new, non-drug approach that may help improve blood sugar control in patients with diagnosed Type 2 Diabetes Mellitus. We are testing a procedure called Radiofrequency Vapor (RFV) Ablation, which gently removes the inner lining of the first part of your small intestine. The small intestine is believed to play an important role in the control of type 2 diabetes. This lining will regenerate, and we hope this process can improve how your body manages blood sugar.
If you join this study, your participation will last up to eight months. The goal is to see if a new procedure can help improve blood sugar control in people with Type 2 Diabetes without adding more medication. First, you will have a screening visit where the study team will review your medical history, check your vital signs, and perform tests such as blood work, an eye exam, and a liver ultrasound to make sure you qualify. If you are eligible, you will enter a 21-60 day run-in period where you will wear a continuous glucose monitor (CGM) and keep a simple diary of your blood sugar and medications. Before the procedure, you will return for another visit for tests like an EKG, chest X-ray, abdominal ultrasound, and blood work. On the day of the procedure, you will come to the hospital after fasting. While you are asleep under anesthesia, the doctor will use an endoscope to reach the first part of your small intestine and apply radiofrequency vapor ablation. This takes about 60-90 minutes. After the procedure, you will have several follow-up visits over six months for exams, blood tests, and sometimes endoscopy with small tissue samples. You will continue using the CGM and your diary throughout the study. This research may lead to new ways to manage diabetes without more drugs, and you will receive close monitoring and care from the Endocrine and Gastroenterology study teams.
Information provided upon request
UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA
Nicholas Shaheen
Center for Gastrointestinal Biology and Disease
Clinical or Medical
Interventional
Diabetes
Stomach, Digestion and Gut Health
25-2971