First of its kind study now recruiting Australians on insulin therapy

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A ground-breaking Australian and world-first study examining a new non-surgical treatment for Type 2 diabetes is now being expanded to include people in advanced stages of the disease.

The Regent-1 Study involves a new endoscopic procedure that regenerates cells that help regulate blood sugar.

Initial results have prompted investigators to review the procedure's potential as a therapy for the reduction, or even possible elimination, of insulin.

According to Sydney gastroenterologist and lead clinical investigator, Dr Adrian Sartoretto, the trial is opening the door for a potential insulin treatment reversal.

“People with Type 2 diabetes who require insulin tend to have a longer history of diabetes and often higher risks of associated complications.

“We’re very excited to be able to extend the Regent-1 Study to people with Type 2 diabetes who are on insulin, to see if they can control their blood sugar levels, reduce their dose of insulin or potentially come off insulin entirely,” said Dr Sartoretto.

“We’re calling on those Australians living with Type 2 diabetes, who can only manage their diabetes through daily insulin injections to reach out to see if they’re eligible.

“The procedure doesn’t require surgery, is similar to a gastroscopy, is done under general anaesthetic, and lasts about 60 minutes,” added Dr Sartoretto.

Diabetes is one of Australia’s most significant health challenges, contributing to several life-threatening diseases including heart disease, stroke and kidney failure, as well as blindness, nerve damage and amputation.

Around one million Australians are currently living with Type 2 diabetes. However, an estimated 500,000 with Type 2 diabetes remain undiagnosed. Each year, an extra 16,000 Type 2 diabetes patients are placed on insulin therapy for the first time.

The new ReCET procedure regenerates the lining of the small intestine using a device that sends out a series of electrical pulses across the duodenal wall. This destroys poorly functioning cells to allow the re-growth of new healthy cells, usually within days, without the need for any cuts, scars or surgery.

Lead co-investigator, Professor David O’Neal, of St Vincent’s Hospital in Melbourne, said, “We have a new understanding of the role of special ‘signalling’ cells in the duodenum which are believed to be responsible for helping to control blood sugar levels.

“By regenerating the lining in the duodenum, we’re pressing a ‘re-set’ button in the small bowel which we believe to by dysfunctional in people living with Type 2 diabetes, essentially restoring that dysfunction and reinstating healthier, functioning signalling cells which allow the body to control sugar circulating in the blood.

“Improving glucose levels will not only reduce the risk of long-term complications associated with diabetes but it could also potentially reduce the financial and psychological burden associated with daily insulin injections,” said Professor O’Neal.

Patients on insulin therapy entering the trial will be treated with an advanced, second-generation device, that covers the entire duodenal wall.

Co-investigator, Professor Elif Ekinci who is the head of Diabetes Austin Health and director of the Australian Centre for Accelerating Diabetes Innovations (ACADI), said, “This cutting-edge trial is now using a new, second-generation device allowing for better duodenal wall regeneration capabilities.

“The new device which we’ll be using for this second phase of the trial, sends pulses across the full circumference of the duodenal wall, whereas when we first started the trial a year ago, we were limited to only being able to resurface half of that early part of the small intestine.

“Once we formally evaluate the effectiveness of the procedure, we’ll certainly be looking at its potential to become an approved therapy for people with Type 2 diabetes down the track, when all the regulatory and trial information has been assessed,” said Professor Ekinci.

Study investigators are aiming to enrol 60 Australians in the second phase of the trial. Patients who take part in the trial will be followed up regularly over a period of at least 12 months for ongoing assessment and support toward better control of blood sugar levels.