Can a New Procedure Help People with Type 2 Diabetes?
A new intestinal procedure is being studied in clinical trials to see if it can help people with type 2 diabetes improve their A1C without the need for insulin.
Clinical Trials Identifier: NCT04419779
Trial Name: REVITALIZE 1 (formerly REVITA-T2Di)
Diabetes Type: Type 2 diabetes
Trial Sponsor: Fractyl Laboratories, Inc.
What is the aim of the study?
Fractyl Health, a biotech company focused on addressing the causes of type 2 diabetes, is testing an intestinal therapy called duodenal mucosal resurfacing (DMR). The REVITALIZE 1 study aims to evaluate whether the DMR procedure using Fractyl’s Revita system is safe, effective, and improves A1C and other diabetes-related targets.
This therapy has been approved in Europe but has not yet received FDA approval in the U.S. In Europe, it is indicated for people with type 2 diabetes who are still producing insulin but have not been able to achieve their desired A1C levels with oral medications, injectable glucose-lowering medications, or long-acting insulin therapy.
Revita has also been indicated to reduce liver fat in people with type 2 diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD) and improve insulin sensitivity in insulin-resistant women with polycystic ovary syndrome.
What is duodenal mucosal resurfacing?
Researchers have identified that a section of our intestines called the duodenum may contribute to insulin resistance. In particular, diets high in fat and sugar cause the lining of our duodenum to thicken over time and stop functioning normally.
The DMR procedure delivers fluids into the gut to help the lining of the duodenum expand. Then using thermal shock (targeted heat treatment), excess layers of lining causing malfunction are removed. The duodenum can then create a new, healthy lining within a few days, essentially “resetting” your gut.
DMR is a one-time, minimally invasive, outpatient procedure performed under either general anesthesia or deep sedation. The whole procedure takes about an hour. Side effects of the procedure may include stomach pain, bleeding, diarrhea, delayed stomach emptying, and nausea.
Potentially, this procedure could help people with type 2 diabetes improve blood sugar management without the need for insulin injections or glucose-lowering medications by increasing insulin sensitivity. In prior clinical trials, no long-term adverse events were reported for up to two years post-procedure.
The FDA has already granted a Breakthrough Device Designation for Revita DMR, which means there’s evidence the treatment shows promise. It also gives Fractyl the go-ahead to accelerate the development, assessment, and review of Revita, hopefully speeding up the timeline for when it could become available in the U.S.
How does the trial work?
For the REVITALIZE 1 study, researchers are recruiting roughly 320 adults with type 2 diabetes and hyperglycemia (high blood sugar) who are taking at least one glucose-lowering medication.
At the initiation of the study, all subjects will be given a fasting plasma glucose test and an A1C test. Participants will then be split into two groups: one will receive DMR treatment and the other will receive a sham treatment (a fake surgical intervention). While both groups will undergo upper endoscopic procedures, the sham procedure will not remove excess layers in the duodenum.
After the procedure, all participants will be monitored for 48 weeks. Subjects who receive the sham procedure will be given the option to undergo DMR at 48 weeks and followed for a further 48 weeks after treatment.
At 24 weeks, researchers will measure the change in A1C from the beginning of the study. They will also measure the proportion of subjects who achieve an A1C of 7% or below, the change in fasting plasma glucose, the percent decrease in body weight, and the proportion of participants who were able to discontinue insulin use.
Why is this study important?
This new procedure has the potential to have positive impacts for people with type 2 diabetes like a lower A1C. Revita could help improve insulin sensitivity and reduce insulin resistance, which is the main cause of type 2 diabetes.
In addition, it could lead to people needing less medication (and less injectable medications) for their diabetes management. Fewer medications also has the benefit of reduced medical costs and potential side effects like hypoglycemia (low blood sugar), which can be associated with insulin.
Are you interested in participating?
You may be eligible if you:
- Are male or female between 21-70 years of age
- Have type 2 diabetes
- Have been taking at least one glucose-lowering agent for 12 weeks, including any of the following: metformin, GLP-1s, GIPs, DPP-4s, TZDs, SGLT-2s, sulfonylureas, meglitinides, or up to 100 units of insulin daily
- Have an A1C that is 7.5% or more, but not greater than 10%
- Are not lactating or pregnant
- Have a body mass index (BMI) over 24 but less than or equal to 40
People with a fasting plasma glucose of 270 mg/dL or above, a fasting C-peptide of less than 0.6 ng/mL, or a recent history of diabetic ketoacidosis may not be eligible to participate. Other exclusions include having type 1 diabetes, taking a medication that can interfere with glucose metabolism, and having recurrent or severe urinary tract infections. See a complete list of inclusion and exclusion criteria here.
This study is recruiting in Arizona, California, Connecticut, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and West Virginia, as well as Belgium, France, Ireland, Italy, the Netherlands, Spain, Switzerland, and the UK. To enroll or learn more about this study, contact Dr. Adelina Paunescu at (781) 526-8152 or email [email protected].
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