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Exploring a Non-Drug Approach for Better Diabetes (T2D) Control

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.

Age & Gender

  • 22 years ~ 65 years
  • Male, Female, Gender Inclusive

Visit Availability

  • Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

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.

Incentives

Information provided upon request

In-person visits:
7
Phone or online visits:
3
Total length of participation:
8 months

Looking for Specific Volunteers

Able to participate:

  • Type 2 Diabetes
  • BMI ≥ 24 and ≤ 40 kg/m2
  • Currently taking 1 or more non-insulin glucose lowering medication

Not eligible if:

  • Type 1 Diabetes
  • Current or previous insulin use (for at least 1 month) over the past 2 years
  • Diabetic Gastroparesis
  • Cancer diagnosis in the last 5 years (non-melanoma skin cancer is ok)

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Secondary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Nicholas Shaheen
Center for Gastrointestinal Biology and Disease

Study Type

Clinical or Medical
Interventional

Study Topics

Diabetes
Stomach, Digestion and Gut Health

IRB Number

25-2971

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