The procedure — which resurfaces the duodenum — was combined with a popular kind of diabetes medication called GLP-1 receptor agonists (such as Victoza, Trulicity, Ozempic) and counseling on lifestyle factors, such as nutrition and physical activity.
Six months after treatments began, three-quarters of participants taking insulin no longer needed it. The amount of fat stored in their livers dropped from 8% to less than 5%.
“The duodenum harbors a broad potential for the treatment of type 2 diabetes and this combination treatment could be a game-changing approach in the treatment of type 2 diabetes and the metabolic syndrome,” said lead researcher Dr. Suzanne Meiring, of Amsterdam University Medical Center in the Netherlands.
This preliminary study included 16 patients, all of whom underwent Duodenal Mucosal Resurfacing (DMR). There was no placebo group or medication-only group for comparison. The study was funded by Fractyl Laboratories, which developed the procedure.
DMR is a minimally invasive procedure that relies on an endoscope — a narrow, flexible tube containing a light and video camera that lets your doctor see inside the body. The endoscope may also carry special tools for treatment. The tube is threaded down the throat into the digestive system.
In DMR, the endoscope is guided to the duodenum, where doctors then resurface, or ablate, its lining. Meiring said it’s not yet clear why the procedure works.
“We think the effects result from a combination of changes that occur when the duodenal mucosa is ablated and rejuvenated,” she said. “We think that changes in hormonal signaling, including the gut hormone GLP-1, bile acid compositions and the microbiome play an important role.”
The 16 participants had type 2 diabetes for an average 11 years. On average, they had been on insulin just under three years. None had taken a GLP-1 receptor agonist before the study.
At the outset, their average A1C levels — an estimate of blood sugar levels over two to three months — were under 8%. After 12 months, the average fell to 6.7%. For most adults, the American Diabetes Association recommends aiming for an A1C below 7%.
After the DMR procedure, patients were given a specific diet for two weeks. After that, they began taking the GLP-1 receptor agonist medication.
Meiring said researchers added the drug because it also targets the duodenum. They hoped it would boost the effects of DMR, “possibly even causing a synergistic effect,” she said.
She said she doesn’t think the positive effects in this study stem from just the drug treatment. Other studies have shown that about 10% of people who start GLP-1 therapy are able to get off insulin, Meiring said. In this study, 75% of those taking insulin were able to stop.
Participants who weren’t insulin-free after 12 months needed only about half the insulin they required before the procedure.
Their average body mass index (BMI) — a measure of body fat based on height and weight — dropped from just under 30 to a near-normal 25.5 after 12 months.
The researchers said there were no serious procedure-related side effects.
Dr. Akankasha Goyal, an endocrinologist at NYU Langone Health in New York City, reviewed the findings.
“This is a simple, single procedure that seems to have amazingly positive results,” she said. “But, this is a small group from a homogenous population. It looks hopeful, but we need to see the larger trials. And, we need to know: how long does the procedure last?”
Dr. Mitchell Roslin, chief of obesity surgery at Lenox Hill Hospital in New York City, called findings “very exciting” but urged caution.
Roslin said the procedure may not have a direct effect on the diabetes. Instead, he said, the positive changes are likely due to weight loss.
“People in clinical trials are motivated to lose weight and they change their eating habits,” Roslin said. “So, the question is: Is the procedure the cause [of the changes] or is it an association? I would bet it’s an association.”
The findings were presented Tuesday at an online meeting of United European Gastroenterology. Findings presented at meetings are typically viewed as preliminary.
Meiring said that placebo-controlled clinical trials of DMR have started or will begin soon at 35 hospitals, including some in the United States.
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Posted: October 2020
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