This content originally appeared on diaTribe. Republished with permission.
By Susannah Chen, Matthew Garza & April Hopcroft
Fractyl Health has developed a new technology that uses heat to “reset” your gut, leading to improvements in glucose levels and weight. Learn more about this technology and its potential benefits, including the ability to reduce insulin needs.
As a part of the digestive system, the gut is one of the largest and most important collections of organs in the body; and it impacts many different aspects of health.
Years of eating foods high in fat and sugar, combined with little physical activity, can lead to buildup and a thickening in the lining of a portion of the gut called the duodenum. Thickening of the duodenum may negatively impact the way it breaks down food for energy, leading to insulin resistance, weight gain, and type 2 diabetes.
Researchers started to wonder: What if you could reset this part of your gut back to its original healthy function? If you could erase the effects of damage due to build-up, could you reverse some of the harmful effects that result from the damage?
To do just that, Fractyl Health has pioneered duodenal mucosal resurfacing (DMR) using what’s been dubbed the Revita system. Data from clinical trials suggests that Revita leads to A1C reductions of 1% or more, improves body weight, and may potentially reduce or eliminate the need for insulin for people with type 2 diabetes.
Revita has been commercially available in the U.K. since 2020 and in Germany since 2023. In the U.S., Revita currently remains limited to investigational use, meaning it may only be used in clinical studies.
How duodenal mucosal resurfacing works
DMR targets the duodenum, the first part of the small intestine located right below the stomach in the digestive tract. As the body digests food, it travels to the duodenum immediately after passing 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 a key role in relaying information between the gut and the brain, detecting nutrients, and triggering responses from the endocrine and central nervous systems.
“The gut itself is a key regulator of metabolism,” said Dr. Kelly White, Fractyl’s vice president of clinical and medical affairs (metabolism is how your body breaks down food and uses it for energy).
The duodenum is particularly important because it sends signals to the organs that have effects on blood sugar and body weight. Over time, unhealthy diets high in fats and sugar can lead to this section of your gut having a thickened lining, negatively affecting your metabolism. This causes the duodenum to become highly active and over-sensitive, which can eventually lead to insulin resistance, weight gain, and type 2 diabetes.
DMR helps to reverse any abnormal nutrient sensing and signaling mechanisms by removing the excess surface layers in the duodenum associated with type 2 diabetes.
“I look at it almost like a metabolic reset,” said White. She explained that the soft tissue lining the duodenum returns to behaving how it did prior to any damage caused by a diet high in fat and sugar.
How long does the procedure take?
DMR is an outpatient (meaning you do not have to stay overnight in a hospital) endoscopic procedure where a doctor can examine directly inside the body using a flexible tube without major surgery or admission to a hospital.
Using a flexible tube inserted through the mouth, the procedure isolates the soft tissue lining from deeper layers of the duodenum. It then removes the excess surface layers using a targeted heated liquid.
In the days following the DMR procedure, the duodenum’s soft tissue lining regenerates, behaving like an undamaged duodenum once again. Dr. Juan Carlos Lopez-Talavera, Fractyl’s former chief medical officer, compared this step to a healing sunburn where damaged skin peels off and new skin emerges.
The Revita DMR procedure is minimally invasive and takes approximately one hour under general anesthesia.
Potential side effects
Side effects of the Revita procedure include stomach pain, sore throat, diarrhea, and nausea, though Lopez-Talavera said that the majority of side effects seen have been very mild.
Unlike a major surgery, the recovery time is pretty quick. The duodenum regenerates a new healthy lining within a few days, so the procedure won’t keep you from your normal routine.
“Patients can resume their daily activities the next day,” said White. “There’s no long recovery period.”
What does data from clinical trials show?
Early research shows that by revitalizing the duodenal soft tissue lining, DMR can help those with type 2 diabetes lower their A1C and better manage their weight. It’s still a work in progress, but researchers suggest these benefits are a result of improved insulin sensitivity following the procedure.
Revita leads to A1C improvements and weight loss
One of Fractyl’s recent trials tested DMR in 56 people with type 2 diabetes. Researchers found that Revita DMR is safe and offers “disease-modifying” metabolic benefits, particularly among those with high fasting blood sugar.
More recent 2024 data from 19 participants with type 2 diabetes showed encouraging improvements in metabolic health:
Three months after the procedure, participants reduced their A1C by at least 1%.
Six months after the procedure, participants reduced their A1C by 1.6% and lost at least 8% of their body weight.
Two year follow-up data from the Revita-1 trial found that participants’ A1C levels were reduced from an average of 8.5% to 7.5%, and remained significantly reduced two years after undergoing the DMR procedure.
DMR could help reduce or eliminate the need for insulin
Some people with type 2 diabetes who undergo DMR might be able to reduce their insulin dose or stop taking insulin entirely.
In a small study of 16 adults on basal insulin, the Revita procedure coupled with lifestyle counseling and a GLP-1 receptor agonist, enabled over half of the participants to stop taking insulin and achieve an A1C less than 7.5% with no serious adverse events.
Revita may have benefits beyond glucose control
Data suggest DMR may improve other metabolic conditions, like diabetes-related liver disease. The majority of participants in the Revita-2 study had fatty liver disease; researchers saw that three months after the study, there was an approximately 35% reduction in liver fat in the DMR group.
“There are so many people with diabetes who also have fatty liver disease, and many of them don’t know that,” said White.
Currently, the procedure is only being studied in people with type 2 diabetes who are on insulin. Fractyl is currently recruiting for its REVITALIZE 1 clinical trial – see here for more information or if you’re eligible to participate.
Learn more about type 2 diabetes treatments and interventions here:
New Intestinal Treatment May Help Type 2 Diabetes Patients Stop Taking Insulin
Encouraging Beta Cell Trial Results Show A1C Reduction in Type 2 Diabetes
Positive Results From New Type 2 Diabetes Cell Therapy Trial