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 without doubt one of the largest and most essential collections of organs within the physique; and it impacts many alternative 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 known as the duodenum. Thickening of the duodenum might negatively influence the way in which it breaks down meals for vitality, resulting in insulin resistance, weight achieve, and sort 2 diabetes.
Researchers began to surprise: What if you happen to might reset this a part of your intestine again to its authentic wholesome operate? If you happen to might erase the results of harm on account of build-up, might you reverse among the dangerous results that end result from the harm?
To just do that, Fractyl Well being has pioneered duodenal mucosal resurfacing (DMR) utilizing what’s been dubbed the Revita system. Knowledge from scientific trials means that Revita results in A1C reductions of 1% or extra, improves physique weight, and should doubtlessly scale back or eradicate the necessity for insulin for individuals with sort 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 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 means of the abdomen.
The duodenum works with the pancreas, liver, and gallbladder to digest meals from the abdomen and soak up 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 techniques.
“The intestine itself is a key regulator of metabolism,” mentioned Dr. Kelly White, Fractyl’s vp of scientific and medical affairs (metabolism is how your physique breaks down meals and makes use of it for vitality).
The duodenum is especially essential 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 might finally result in insulin resistance, weight achieve, 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 sort 2 diabetes.
“I have a look at it nearly like a metabolic reset,” mentioned White. She defined that the comfortable tissue lining the duodenum returns to behaving the way it did previous to any harm attributable to a weight loss program excessive in fats and sugar.
How lengthy does the process take?
DMR is an outpatient (which means you wouldn’t have to remain in a single day in a hospital) endoscopic process the place a health care provider 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 means of the mouth, the process isolates the comfortable 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 comfortable 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 side effects
Unintended effects of the Revita process embody abdomen ache, sore throat, diarrhea, and nausea, although Lopez-Talavera mentioned that almost all of unwanted side effects seen have been very gentle.
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 received’t preserve you out of your regular routine.
“Sufferers can resume their day by day actions the following day,” mentioned White. “There’s no lengthy restoration interval.”
What does knowledge from scientific trials present?
Early analysis exhibits that by revitalizing the duodenal comfortable tissue lining, DMR can assist these with sort 2 diabetes decrease their A1C and higher handle their weight. It’s nonetheless a piece in progress, however researchers recommend these advantages are a results of improved insulin sensitivity following the process.
Revita results in A1C enhancements and weight reduction
One among Fractyl’s latest trials examined DMR in 56 individuals with sort 2 diabetes. Researchers discovered that Revita DMR is secure and provides “disease-modifying” metabolic advantages, significantly amongst these with excessive fasting blood sugar.
More moderen 2024 knowledge from 19 contributors with sort 2 diabetes confirmed encouraging enhancements in metabolic well being:
- Three months after the process, contributors decreased their A1C by at the least 1%.
- Six months after the process, contributors decreased their A1C by 1.6% and misplaced at the least 8% of their physique weight.
Two 12 months follow-up knowledge from the Revita-1 trial discovered that contributors’ A1C ranges have been decreased from a median of 8.5% to 7.5%, and remained considerably decreased two years after present process the DMR process.
DMR might assist scale back or eradicate the necessity for insulin
Some individuals with sort 2 diabetes who endure DMR may be capable to scale back their insulin dose or cease taking insulin solely.
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 contributors to cease taking insulin and obtain an A1C lower than 7.5% with no severe antagonistic occasions.
Revita might have advantages past glucose management
Knowledge recommend DMR might enhance different metabolic circumstances, like diabetes-related liver illness. Nearly all of contributors 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,” mentioned White.
At the moment, the process is simply being studied in individuals with sort 2 diabetes who’re on insulin. Fractyl is at present recruiting for its REVITALIZE 1 scientific trial – see right here for extra info or if you happen to’re eligible to take part.
