This content material initially appeared on diaTribe. Republished with permission.
By Susannah Chen, Matthew Garza & April Hopcroft
As part of the digestive system, the intestine is among the largest and most vital collections of organs within the physique; and it impacts many various facets of well being.
Years of consuming meals excessive in fats and sugar, mixed with little bodily exercise, can result in buildup and a thickening within the lining of a portion of the intestine referred to as the duodenum. Thickening of the duodenum might negatively impression the best way it breaks down meals for power, resulting in insulin resistance, weight acquire, and kind 2 diabetes.
Researchers began to surprise: What should you might reset this a part of your intestine again to its authentic wholesome operate? Should you might erase the results of injury resulting from build-up, might you reverse a few of the dangerous results that end result from the harm?
To do exactly that, Fractyl Well being has pioneered duodenal mucosal resurfacing (DMR) utilizing what’s been dubbed the Revita system. Information from scientific trials means that Revita results in A1C reductions of 1% or extra, improves physique weight, and should probably scale back or remove the necessity for insulin for individuals with kind 2 diabetes.
Revita has been commercially obtainable within the U.Ok. since 2020 and in Germany since 2023. Within the U.S., Revita at present stays restricted to investigational use, which means it might solely be utilized in scientific research.
How duodenal mucosal resurfacing works
DMR targets the duodenum, the primary a part of the small gut situated proper under the abdomen within the digestive tract. Because the physique digests meals, it travels to the duodenum instantly after passing by way of the abdomen.
The duodenum works with the pancreas, liver, and gallbladder to digest meals from the abdomen and take in water and vitamins. It additionally performs a key position in relaying info between the intestine and the mind, detecting vitamins, and triggering responses from the endocrine and central nervous methods.
“The intestine itself is a key regulator of metabolism,” stated Dr. Kelly White, Fractyl’s vice chairman of scientific and medical affairs (metabolism is how your physique breaks down meals and makes use of it for power).
The duodenum is especially vital as a result of it sends indicators to the organs that have an affect on blood sugar and physique weight. Over time, unhealthy diets excessive in fat and sugar can result in this part of your intestine having a thickened lining, negatively affecting your metabolism. This causes the duodenum to grow to be extremely lively and over-sensitive, which may finally result in insulin resistance, weight acquire, and kind 2 diabetes.
DMR helps to reverse any irregular nutrient sensing and signaling mechanisms by eradicating the surplus floor layers within the duodenum related to kind 2 diabetes.
“I take a look at it nearly like a metabolic reset,” stated White. She defined that the smooth tissue lining the duodenum returns to behaving the way it did previous to any harm brought on by a food regimen excessive in fats and sugar.
How lengthy does the process take?
DMR is an outpatient (which means you shouldn’t have to remain in a single day in a hospital) endoscopic process the place a physician can look at straight contained in the physique utilizing a versatile tube with out main surgical procedure or admission to a hospital.
Utilizing a versatile tube inserted by way of the mouth, the process isolates the smooth tissue lining from deeper layers of the duodenum. It then removes the surplus floor layers utilizing a focused heated liquid.
Within the days following the DMR process, the duodenum’s smooth tissue lining regenerates, behaving like an undamaged duodenum as soon as once more. Dr. Juan Carlos Lopez-Talavera, Fractyl’s former chief medical officer, in contrast this step to a therapeutic sunburn the place broken pores and skin peels off and new pores and skin emerges.
The Revita DMR process is minimally invasive and takes roughly one hour below basic anesthesia.
Potential negative effects
Unintended effects of the Revita process embrace abdomen ache, sore throat, diarrhea, and nausea, although Lopez-Talavera stated that almost all of negative effects seen have been very delicate.
Not like a significant surgical procedure, the restoration time is fairly fast. The duodenum regenerates a brand new wholesome lining inside a number of days, so the process received’t maintain you out of your regular routine.
“Sufferers can resume their each day actions the subsequent day,” stated White. “There’s no lengthy restoration interval.”
What does knowledge from scientific trials present?
Early analysis exhibits that by revitalizing the duodenal smooth tissue lining, DMR will help these with kind 2 diabetes decrease their A1C and higher handle their weight. It’s nonetheless a piece in progress, however researchers counsel these advantages are a results of improved insulin sensitivity following the process.
Revita results in A1C enhancements and weight reduction
One in all Fractyl’s current trials examined DMR in 56 individuals with kind 2 diabetes. Researchers discovered that Revita DMR is protected and gives “disease-modifying” metabolic advantages, significantly amongst these with excessive fasting blood sugar.
More moderen 2024 knowledge from 19 contributors with kind 2 diabetes confirmed encouraging enhancements in metabolic well being:
- Three months after the process, contributors diminished their A1C by not less than 1%.
- Six months after the process, contributors diminished their A1C by 1.6% and misplaced not less than 8% of their physique weight.
Two 12 months follow-up knowledge from the Revita-1 trial discovered that contributors’ A1C ranges had been diminished from a mean of 8.5% to 7.5%, and remained considerably diminished two years after present process the DMR process.
DMR might assist scale back or remove the necessity for insulin
Some individuals with kind 2 diabetes who bear DMR would possibly be capable to scale back their insulin dose or cease taking insulin solely.
In a small research of 16 adults on basal insulin, the Revita process coupled with way of life counseling and a GLP-1 receptor agonist, enabled over half of the contributors to cease taking insulin and obtain an A1C lower than 7.5% with no critical opposed occasions.
Revita might have advantages past glucose management
Information counsel DMR might enhance different metabolic circumstances, like diabetes-related liver illness. The vast majority of contributors within the Revita-2 research had fatty liver illness; researchers noticed that three months after the research, there was an roughly 35% discount in liver fats within the DMR group.
“There are such a lot of individuals with diabetes who even have fatty liver illness, and plenty of of them don’t know that,” stated White.
At present, the process is simply being studied in individuals with kind 2 diabetes who’re on insulin. Fractyl is at present recruiting for its REVITALIZE 1 scientific trial – see right here for extra info or should you’re eligible to take part.
