- A new procedure could help eliminate the need for insulin for some people with type 2 diabetes.
- The results of a clinical trial involving the new technique were unveiled today at a conference.
- The outpatient procedure involves inserting a catheter into a part of the intestine to destroy mucosal cells that have changed as a result of diabetes.
While insulin — the primary way of treating and managing diabetes — has been around for more than a century, skyrocketing insulin prices in the past decade have led to desperate actions from people with diabetes.
Some have made caravan trips to Canada and Mexico, countries that offer much cheaper versions of the same drugs sold in the United States.
Others have died from rationing their supply of a drug they couldn’t afford.
However, a new procedure could eliminate the need for insulin for millions of Americans with type 2 diabetes by restoring the body’s ability to produce and regulate insulin naturally.
And those who undergo the procedure won’t even need to spend a night in the hospital.
The procedure is called duodenal mucosal resurfacing, or DMR.
The outpatient procedure involves inserting a catheter into the duodenum — the first part of the intestine — and then “ablating,” or destroying, mucosal cells that have changed in the process of the person developing diabetes.
Destroying these tissues allows the mucosa to regrow new, healthy cells.
In a new pilot trial out of the Netherlands, researchers said 75 percent of insulin-dependent people with type 2 diabetes no longer required insulin 6 months after the DMR procedure was conducted.
The rest of the participants saw their required insulin doses drop by half, according to research presented today at UEG Week 2020 Virtual.
In addition to lower insulin resistance, study participants also saw significant reductions in body mass index scores from an average of 29.8 kilograms per square meter (kg/m2) at the beginning of the study to 27.2 kg/m2.
They also nearly halved the percentage of fat in their livers after 6 months, from 8.1 percent to 4.6 percent.
The results of the Dutch study are paving the way for a new, multinational trial further exploring the efficacy of the technique with 300 people worldwide, including participants at 25 U.S. testing sites.
“Despite having a huge number of medicines that are approved — I think there are around 57 or 58 drugs approved to lower blood sugar in the United States — more than 50 percent of patients with type 2 diabetes are poorly controlled,” said Dr. Harith Rajagopalan, co-founder and chief executive officer of biotechnology company Fractyl and co-inventor for the DMR technique.
“And within the decade, we’re going to spend a trillion dollars a year managing diabetes and its complications. So it’s a massive healthcare problem and crisis that is only growing.”
DMR could change all that.
“It’s potentially the first therapy to enable people who are on insulin to not have to take insulin anymore,” Rajagopalan said.
The origins of the DMR technique came after observing that people who had gastric bypass procedures often found themselves cured of their type 2 diabetes.
“Bariatric surgery pointed the way I think in two key ways,” Rajagopalan told Healthline.
“The first way is to show that you can do a procedure on the gut, not even touch the pancreas and have the opportunity to cure type 2 diabetes. That’s a major sort of mind-blowing paradigm shift in terms of how to think about treating a disease that you thought was a chronic disease, but you can make it go away with an intervention on the gut.
“And the second thing about the bariatric surgery is that it’s an accidental experiment that proves that the gut is a root cause of the disease.”
Dr. Sangeeta Kashyap, the principal investigator on the upcoming multinational study, agreed.
“This would be the first procedure that’s done endoscopically that would produce a similar benefit to gastric bypass without having gastric bypass,” she told Healthline.
That has a twofold benefit, she said, since bariatric surgery is a major surgery that many people with diabetes aren’t heavy enough to qualify for under their health insurance, or people simply don’t want to undergo a major surgical procedure even if they qualify.
DMR, being an endoscopic surgery, is much less invasive as well as more affordable and accessible.
“As great as gastric bypass surgery is, there’s a limit,” Rajagopalan said. “We do about 250,000 gastric bypass surgeries in the United States. We do 20 million endoscopy procedures.”
While the multinational study is spooling up, the Revita DMR technique has already received a CE mark in Europe, an indication a product has met health, safety, and environmental protection requirements.
Citizens in the European Union could start receiving the procedure in the next year or two, Rajagopalan said, with the United States possibly not far behind.
“People who are diabetic on insulin usually have had diabetes for a long duration of time, and develop these complications like fatty liver, cirrhosis, heart disease, and other complications. So having a treatment that could potentially make diabetes better and get people off insulin is a big deal,” Kashyap said.
“This is very innovative. There’s absolutely nothing like it.”