This content originally appeared on Diatribe. It was reissued with permission.
by Susanna Chen, Matthew Garza, April Hopcroft
As part of the digestive system, the intestine is one of the largest and most important collections of organs in the body. And it affects many different aspects of health.
Years of physical activity, where you rarely experience fat and sugary foods, can lead to the accumulation and thickening of the lining of some of the intestines called the duodenum. Thickening of the duodenum adversely affects the way energy food breaks down, leading to insulin resistance, weight gain and type 2 diabetes.
The researchers began to wonder. What if you could restore this part of your intestine to its original healthy function? If we can eliminate the effects of damage caused by accumulation, can we reverse some of the harmful effects that arise from the damage?
To do that, Fractyl Health pioneers duodenal mucosa resurfacing (DMR) using what is called the Revita system. Data from clinical trials suggest that Revita leads to a 1% or more reduction in A1C, improving weight, potentially reducing or eliminating the need for insulin in patients with type 2 diabetes.
Revita has been available in the UK since 2020 and since 2023. In the US, Revita is currently limited to clinical trial use. This means it may only be used in clinical research.
How duodenal mucosa resurfacing works
DMR targets the duodenum, the first part of the small intestine, just below the stomach of the gastrointestinal tract. Once the body digests food, it travels to the duodenum just after it passes through the stomach.
The duodenum works with the pancreas, liver and gallbladder to digest food from the stomach and absorb water and nutrients. It also plays an important role in relaying information between the gut and the brain, detecting nutrients, and inducing responses from the endocrine and central nervous system.
“The gut itself is an important regulator of metabolism,” says Dr. Kelly White, PhD, Vice President of Clinical and Medical Affairs at Fractil (metabolism is the way your body breaks down food and uses it for energy).
The duodenum is especially important because it sends signals to organs that affect blood sugar and weight. Over time, an unhealthy diet high in fat and sugar can thicken this section of your intestine and lead to negative effects on your metabolism. This can make the duodenum very active and overly sensitive, which can ultimately lead to insulin resistance, weight gain and type 2 diabetes.
DMR helps reverse abnormal nutritional sensing and signaling mechanisms by removing excess surface layers of the duodenum associated with type 2 diabetes.
“I see it like a metabolic reset,” White said. She explained that soft tissue above the duodenum returns to behaving how it was done before the damage caused by a diet high in fat and sugar.
How long does the procedure take?
DMR is an endoscopic procedure that allows doctors to directly examine in the body in outpatients (which means there is no need to stay in a hospital overnight) using flexible tubes without major surgery or hospital admission.
Using a flexible tube inserted through the mouth, this procedure separates the soft tissue lining from the deeper layer of the duodenum. Next, use the target heating solution to remove excess surface layer.
For several days after the DMR procedure, the soft tissue lining of the duodenum regenerates and again behaves like an intact duodenum. Dr. Juan Carlos Lopez-Talavera, former chief medical officer at Fractyl, compared the step with a healing tan where the damaged skin is peeling off and new skin appears.
The Revita DMR procedure is minimally invasive and takes approximately 1 hour under general anesthesia.
Potential side effects
Side effects of the revita procedure include stomach pain, sore throat, diarrhea and nausea, but Lopez Talabella said most of the side effects seen are very mild.
Unlike major surgeries, recovery times are fairly quick. This step does not hinder you from a normal routine as the duodenum regenerates a new healthy lining within a few days.
“Patients can resume their daily activities the next day,” White said. “There’s no long recovery period.”
What do clinical trial data show?
Early studies have shown that by activating the lining of the soft duodenal tissue, DMR can help people with type 2 diabetes lower A1C and better manage their weight. Although it is still a work in progress, researchers suggest that these benefits are the result of improved insulin sensitivity following the procedure.
Revita leads to improved A1C and weight loss
One recent Fractyl test tested DMR in 56 people with type 2 diabetes. Researchers have discovered that revita DMR is safe, offering metabolic benefits that “corrects the disease” especially among people with high fasting blood sugar levels.
Recent 2024 data from 19 participants with type 2 diabetes showed encouraged improvements in metabolic health.
- Three months after treatment, participants reduced A1C by at least 1%.
- Six months after treatment, participants lost A1C by 1.6% and lost at least 8% of their body weight.
Two-year follow-up data for the Revita-1 trial showed that participants’ A1C levels decreased from an average of 8.5% to 7.5%, and significantly decreased 2 years after the DMR procedure.
DMR helps reduce or eliminate the need for insulin
Some people with type 2 diabetes undergoing DMR may be able to reduce the dose of insulin or stop taking it completely.
In a small-dose study of 16 adults with basal insulin, the revita procedure, coupled with lifestyle counseling and GLP-1 receptor agonists, allowed more than half of participants to stop taking insulin and achieve A1c in <7.5% without serious adverse events.
Revita has advantages beyond glucose control
Data suggest that DMR may improve other metabolic conditions, such as diabetes-related liver disease. The majority of participants in the Revita-2 study suffered from fatty liver disease. The researchers saw a 35% decrease in liver fat in the DMR group three months after the study.
“There are so many people with diabetes who suffer from fatty liver disease, and many of them don’t know about it,” White said.
Currently, this procedure is only studied in people with type 2 diabetes who use insulin. Fractyl is currently recruiting to reinvigorate a single clinical trial. For more information, please see here if you are eligible to participate.
(TagStoTRASSLATE)A1C(T)Beta cells(T)Duodenum(T)Insulin(T)Intensive management(T)Intestinal (T)Surgery(T)Type 2 diabetes
