This content material initially appeared on diaTribe. Republished with permission.
by Susanna Chen, Matthew Garza, April Hopcroft
The intestines, a part of the digestive system, are one of many largest and most necessary collections of organs within the physique. And it impacts many points of well being.
Years of consuming meals excessive in fats and sugar and never getting sufficient train could cause buildup and thickening of the liner of the a part of the gut known as the duodenum. A thickened duodenum can negatively impression how meals is damaged down for vitality, resulting in insulin resistance, weight acquire, and kind 2 diabetes.
Researchers started to surprise what would occur if this a part of the gut may very well be reset and returned to its earlier wholesome perform. If we may erase the results of cumulative injury, may we reverse among the deleterious results of harm?
To just do that, Fractyl Well being pioneered duodenal mucosal resurfacing (DMR) utilizing one thing known as the Revita system. Scientific trial knowledge means that Revita could cut back A1C by greater than 1%, enhance weight, and cut back or eradicate the necessity for insulin in individuals with kind 2 diabetes.
Revita has been commercially out there within the UK since 2020 and in Germany from 2023. In the US, Revita is presently restricted to investigational use, that means it could actually solely be utilized in scientific research.
Mechanism of resurfacing of duodenal mucosa
DMR targets the duodenum, the primary a part of the small gut positioned slightly below the abdomen within the gastrointestinal tract. When the physique digests meals, the meals passes by means of the abdomen and shortly strikes into the duodenum.
The duodenum works with the pancreas, liver, and gallbladder to digest meals from the abdomen and take in water and vitamins. It additionally performs an necessary position in relaying info between the intestine and mind, detecting vitamins, and triggering responses from the endocrine and central nervous techniques.
“The intestine itself is a key regulator of metabolism,” says Dr. Kelly White, vice chairman of scientific drugs at Fractyl. (Metabolism is the way in which the physique breaks down meals and makes use of it for vitality. is).
The duodenum is especially necessary as a result of it sends indicators to organs that have an effect on blood sugar ranges and weight. Over time, an unhealthy weight-reduction plan excessive in fats and sugar could cause the liner on this a part of the gut to thicken, negatively impacting your metabolism. This may trigger the duodenum to develop into hyperactive and irritable, which might ultimately result in insulin resistance, weight acquire, and kind 2 diabetes.
DMR helps reverse aberrant nutrient sensing and signaling mechanisms by eradicating extra floor layer of the duodenum related to kind 2 diabetes.
“I consider this as a form of metabolic reset,” White stated. She defined that the delicate tissue lining the duodenum returns to its state earlier than it was broken by a weight-reduction plan excessive in fats and sugar.
How lengthy does the method take?
DMR is an outpatient (i.e., no in a single day hospital keep) endoscopic process that enables docs to look at immediately contained in the physique utilizing a versatile tube with out in depth surgical procedure or hospitalization. .
This process makes use of a versatile tube inserted by means of the mouth to separate the delicate tissue lining from the deeper layers of the duodenum. Then take away the surplus floor layer utilizing the specified heated liquid.
Within the days following the DMR process, the delicate tissue lining of the duodenum regenerates and capabilities like an undamaged duodenum once more. Dr. Juan Carlos López Talavera, Fractyl’s former chief medical officer, likened this step to a therapeutic sunburn, the place broken pores and skin sloughs off and new pores and skin emerges.
The Revita DMR process is minimally invasive and takes roughly 1 hour beneath normal anesthesia.
potential unwanted effects
Unintended effects of the Revita surgical procedure embody belly ache, sore throat, diarrhea and nausea, however Dr. López Talavera stated a lot of the unwanted effects seen had been very delicate.
Not like main surgical procedure, restoration time is way sooner. The process doesn’t intrude with regular life, because the duodenum regrows a brand new, wholesome lining inside just a few days.
“Sufferers can resume their every day actions the following day,” Dr. White stated. “There is not any lengthy restoration interval.”
What do the scientific trial knowledge present?
Early research have proven that DMR may help decrease A1C and enhance weight administration in individuals with kind 2 diabetes by activating the delicate tissue lining of the duodenum. Though nonetheless being studied, researchers recommend that these advantages are a results of improved insulin sensitivity after this process.
Revita results in improved A1C and weight reduction
One in every of Fractyl’s current trials examined DMR in 56 sufferers with kind 2 diabetes. Researchers discovered that Revita DMR was protected and had “disease-modifying” metabolic results, particularly in individuals with excessive fasting blood sugar ranges.
Current 2024 knowledge from 19 individuals with kind 2 diabetes confirmed encouraging enhancements in metabolic well being.
- Three months after therapy, individuals’ A1C decreased by no less than 1%.
- Six months after therapy, individuals had a 1.6% discount in A1C and no less than 8% weight reduction.
Two-year follow-up knowledge from the Revita-1 trial discovered that individuals’ A1C ranges decreased from a median of 8.5% to 7.5% and remained considerably diminished two years after present process the DMR process .
DMR could assist cut back or eradicate the necessity for insulin
Some individuals with kind 2 diabetes who bear DMR could possibly cut back their insulin dose or cease utilizing insulin altogether.
In a small examine of 16 adults taking basal insulin, the Revita process, which mixed life-style counseling and a GLP-1 receptor agonist, led greater than half of individuals to cease utilizing insulin. , we had been in a position to obtain A1C <7.5% with out critical opposed occasions.
Revita could have advantages past blood sugar management
Information recommend that DMR could enhance different metabolic situations comparable to diabetes-related liver illness. The vast majority of individuals within the Revita-2 examine had fatty liver illness. Three months into the examine, the researchers noticed a discount in liver fats of about 35% within the DMR group.
“So many individuals with diabetes have fatty liver illness, and many do not comprehend it,” White says.
Presently, this therapy is simply being studied in sufferers with kind 2 diabetes who’re taking insulin. Fractyl is presently recruiting individuals for the REVITALIZE 1 scientific trial. For extra info or to see in the event you’re eligible, see right here.
