Type 2 Diabetes is a progressive disease in which the body has difficulty maintaining normal blood sugar (glucose) levels. Over time, excess sugar in the blood can damage blood vessels, kidneys, and other tissues in the body, causing complications such as high blood pressure, heart disease, stroke, neuropathy, kidney damage, eye damage and foot ulcers among others.
Normalizing and controlling blood glucose levels can prevent or slow down the progression of the disease and is a primary goal of diabetes management.
The duodenum is the first part of the small intestine. It connects the stomach to the rest of the digestive tract.
As the first absorptive part of the digestive tract that sees the intake of food, the duodenum plays an important role in signaling the rest of the body to prepare for the nutrients that it is about to receive.
In patients with Type 2 Diabetes, the cells in the duodenal lining, or mucosa, that are responsible for this signaling are not functioning properly; this can contribute to an imbalance in blood sugar levels.
Duodenal Mucosal Regeneration or DMR is an endoscopic procedure that is designed to eliminate these poorly functioning cells in the mucosa so the body will regrow new cells that signal properly. This is intended to help the body better regulate blood sugar levels.
The DyaMX DMR procedure is done in an endoscopy suite in a hospital or an outpatient center. Patients will be under general anesthesia for the procedure. During the procedure, a specialized doctor called a gastroenterologist, will use a small flexible camera (endoscope) to guide a special catheter through the mouth and past the stomach into the duodenum. This catheter is designed to apply pulsed electric fields across the mucosa, or lining, of the duodenum. These electric fields will destabilize the targeted cells of the mucosa and initiate the regeneration or regrowth of healthy cells – including the signaling cells that help the body manage blood glucose levels.
Because the DyaMX procedure is done endoscopically, this means there will be no incisions (cuts or scars).
While the recovery experience is not completely known at this time most individuals should be able to go home the day of the procedure. Patients may experience some abdominal discomfort that should pass in a short time.
Normal physical activity can usually be resumed the next day.
The Regent-1 Clinical Trial will evaluate the safety and feasibility of the DyaMX procedure in the treatment of patients with Type 2 Diabetes.
If you are interested in the DyaMX procedure and the REGENT-1 Clinical Trial, please complete the information below*.
You may be eligible to be included in the study if you:
While participation in the clinical trial will require regular interaction with healthcare professionals, steps will be taken to limit the exposure potential and remote visits will be utilized if necessary.
A study coordinator will discuss these visits, and other COVID precautions, in detail with participants.