Phase 2 clinical trial investigates the effectiveness of innovative procedure to control Type 2 diabetes

More than 37 million Americans have diabetes, and approximately 90-95% have Type 2 diabetes.

Diabetes is a chronic condition where the body does not produce or effectively use insulin. A lack of insulin leads to raised blood glucose (sugar) levels, which can cause heart disease and stroke, kidney disease, nerve damage and other severe complications.

Keck Medicine of USC has launched a Phase 2 clinical trial investigating the effectiveness of a new outpatient, nonsurgical endoscopic procedure in stabilizing blood glucose levels for patients.

Currently, the only treatment for diabetes not managed with lifestyle changes are oral medications or, in the case of advanced disease, insulin injections, both of which can be costly or have side effects. If this therapy is proven effective, it could eliminate the need for medication or insulin, or potentially prevent disease progression so it does not lead to organ failure and other debilitating conditions."

Luke Putnam, MD, lead investigator of the clinical trial and gastrointestinal surgeon with Keck Medicine

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This innovative procedure is designed for patients before they require insulin and targets the duodenum, the first part of the small intestine that works with the pancreas to regulate insulin and blood glucose levels.

Recent data suggests the duodenum plays an important role in glucose regulation, and in patients with Type 2 diabetes, the cells lining the duodenum become damaged.

The clinical trial is testing a device inserted via an endoscope into the duodenum that ablates (removes) the poorly functioning cells through precise, controlled electrical pulses.

The study researchers hypothesize that ablating the damaged cells will promote the regrowth of healthy cells, which will better regulate blood glucose levels.

The procedure takes about an hour and is done under general anesthetic. Patients are discharged the same day and can continue normal activities a few days later.

"Previous studies have shown that ablation of cells in the duodenum is effective in controlling blood sugar levels, so we are optimistic this study will produce successful results," said Putnam.

Clinical trial participant Mark Canning, a 60-year-old Los Angeles resident who was diagnosed with Type 2 diabetes in 2015, is seeing progress controlling his blood glucose since undergoing the procedure in January. "My blood sugar levels are falling, and I am feeling very encouraged," he said.

The clinical trial is currently enrolling new patients. To qualify for the study, patients must be between the ages of 22-65 and have a history of Type 2 diabetes between three to 10 years. Participants can be on oral medications but not insulin.