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 necessary collections of organs within the physique; and it impacts many various elements 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 way in which it breaks down meals for power, resulting in insulin resistance, weight acquire, and kind 2 diabetes.
Researchers began to surprise: What for those who may reset this a part of your intestine again to its authentic wholesome operate? In the event you may erase the results of injury attributable to build-up, may you reverse among the dangerous results that end result from the injury?
To just do that, Fractyl Well being has pioneered duodenal mucosal resurfacing (DMR) utilizing what’s been dubbed the Revita system. Information from medical trials means that Revita results in A1C reductions of 1% or extra, improves physique weight, and will 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 could solely be utilized in medical 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 function in relaying info between the intestine and the mind, detecting vitamins, and triggering responses from the endocrine and central nervous programs.
“The intestine itself is a key regulator of metabolism,” stated Dr. Kelly White, Fractyl’s vp of medical and medical affairs (metabolism is how your physique breaks down meals and makes use of it for power).
The duodenum is especially necessary as a result of it sends alerts to the organs that affect 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 change into extremely energetic and over-sensitive, which might finally result in insulin resistance, weight acquire, and sort 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 have a look at it nearly like a metabolic reset,” stated White. She defined that the gentle tissue lining the duodenum returns to behaving the way it did previous to any injury attributable to a weight-reduction plan 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 immediately 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 gentle 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 gentle 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 common anesthesia.
Potential unwanted effects
Unwanted effects of the Revita process embody abdomen ache, sore throat, diarrhea, and nausea, although Lopez-Talavera stated that almost all of unwanted 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 couple of days, so the process gained’t hold 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 medical trials present?
Early analysis reveals that by revitalizing the duodenal gentle tissue lining, DMR may 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 provides “disease-modifying” metabolic advantages, significantly amongst these with excessive fasting blood sugar.
Newer 2024 knowledge from 19 members with kind 2 diabetes confirmed encouraging enhancements in metabolic well being:
- Three months after the process, members lowered their A1C by no less than 1%.
- Six months after the process, members lowered their A1C by 1.6% and misplaced no less than 8% of their physique weight.
Two yr follow-up knowledge from the Revita-1 trial discovered that members’ A1C ranges had been lowered from a mean of 8.5% to 7.5%, and remained considerably lowered two years after present process the DMR process.
DMR may assist scale back or remove the necessity for insulin
Some individuals with kind 2 diabetes who endure DMR may be capable to scale back their insulin dose or cease taking insulin completely.
In a small examine of 16 adults on basal insulin, the Revita process coupled with life-style counseling and a GLP-1 receptor agonist, enabled over half of the members to cease taking insulin and obtain an A1C lower than 7.5% with no critical adversarial 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 members within the Revita-2 examine had fatty liver illness; researchers noticed that three months after the examine, 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 lots of of them don’t know that,” stated White.
At present, the process is barely being studied in individuals with kind 2 diabetes who’re on insulin. Fractyl is at present recruiting for its REVITALIZE 1 medical trial – see right here for extra info or for those who’re eligible to take part.
