Could an Intestinal Procedure Be the Future of Type 2 Diabetes Therapy?
Fractyl Health, a company that has pioneered a procedure called Duodenal Mucosal Resurfacing, announced on Feb. 8 that it has begun offering its procedure as a type 2 diabetes treatment in Germany.
DMR is an outpatient endoscopic procedure, meaning it is performed nonsurgically using a flexible tube that is inserted directly into the body; the procedure does not require admission to a hospital.
Initial Revita procedures will take place at EVK Hospital in Düsseldorf, as well as other select hospitals in Germany. This is the first time such a procedure has been commercially available in the EU; it has been commercially available in the UK since 2020. In the United States, Revita currently remains limited to investigational use only, meaning it may only be used in clinical studies.
Last week, Fractyl also announced an update from one of its trials that suggests undergoing DMR may reduce or even eliminate the need for insulin in some patients with type 2 diabetes.
How Duodenal Mucosal Resurfacing (DMR) Works
DMR targets the duodenum, the first part of the small intestine.
The duodenum works with the pancreas, liver, and gallbladder to digest food coming from the stomach and to 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 that have effects on blood sugar and body weight.
Over time, the combination of reduced physical activity and diets high in fat and sugar can lead to the duodenum having a thickened lining, which may negatively impact the way it breaks down food for energy, leading to insulin resistance, weight gain, and type 2 diabetes.
DMR helps to reverse these abnormal nutrient sensing and signaling mechanisms by removing these excess surface layers in the duodenum. Using a flexible tube inserted through the mouth, the procedure isolates the soft tissue lining from deeper layers of the duodenum and then removes 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.
In an interview with diaTribe, Dr. Juan Carlos Lopez-Talavera, Fractyl’s former chief medical officer, compared this step to a healing sunburn where sunburned skin peels off and new skin emerges.
“I look at it almost like a metabolic reset,” said Kelly White, Fractyl’s vice president of clinical and medical affairs, explaining that the duodenum soft tissue lining returns to behaving how it did prior to any damage caused by a diet high in fat or sugar.
Early research shows that by revitalizing the duodenal soft tissue lining, DMR can also help those with type 2 diabetes who’ve undergone this procedure to lower their A1C, better manage their weight, and even reduce their medications.
How Long Does the Procedure Take?
The procedure is relatively straightforward. It is minimally invasive, done in an outpatient setting (which means you do not have to stay overnight in a hospital), and takes roughly one hour under anesthesia.
How Long Does It Take to Recover from DMR?
People who receive the procedure can resume normal activities the next day.
Potential Side Effects of the Revita DMR Procedure
Side effects of the Revita procedure include stomach pain, sore throat, diarrhea, and nausea. “The majority of the symptoms we have seen have been very mild,” said Lopez-Talavera.
Early Clinical Trial Results of DMR for Type 2 Diabetes
A number of clinical trial results suggest the Revita DMR procedure is both safe and effective. It’s important to note, however, that early clinical trials have only included a small number of participants.
A 2020 study concluded that DMR is not only safe but it also improves blood sugar levels in type 2 diabetes patients with high A1C levels. Fractyl’s randomized, double-blind Revita-2 trial published last February also concluded that Revita DMR is not only safe, but it also offers “disease-modifying” metabolic benefits in people, particularly those with high fasting blood sugar, who have type 2 diabetes.
The procedure has positive results beyond glucose management as well. The majority of participants in the 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.
Last year Fractyl also published data from a two-year follow up of 27 people with type 2 diabetes who were on at least one glucose-lowering medication; it showed that participants’ A1C levels were reduced from an average of 8.5% to 7.5%, and remained significantly reduced 2 years after undergoing the DMR procedure. And in a small 2020 study of 16 adults with type 2 diabetes on basal insulin, the procedure, coupled with lifestyle counseling and a GLP-1 receptor agonist, enabled over half of the participants to be taken off insulin and achieve an A1C less than 7.5% with no serious adverse events.
Last week Fractyl also announced an update from one of its current trials that suggests undergoing DMR may reduce or even eliminate the need for insulin in some people with type 2 diabetes.