Fractyl - RevitaT2Di Pivotal Study
Research type
Research Study
Full title
A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects with Type 2 Diabetes on Insulin therapy
IRAS ID
320861
Contact name
Prash R J Vas
Contact email
Sponsor organisation
Fractyl Laboratories Inc
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 6 months, 14 days
Research summary
Purpose of this research study is to determine the effect of the Revita system on blood glucose control in people with type 2 diabetes on insulin treatment.
Researchers believe that the first layer of the duodenum (part of the small intestine after the stomach) has an important role in the control of type 2 diabetes. This layer (called the mucosa) is responsible for the absorption of nutrients and it is believed to be thickened in patients with type 2 diabetes.
In the Fractyl Revita procedure, the first layer (mucosa) of the duodenum is heated using the Fractyl Revita System. This initiates a healing process to create a new
mucosal layer, thereby modifying the function. This heating and healing process is called duodenal mucosal resurfacing (DMR).
By treating the mucosa to correct the thickening of this layer of the duodenum, the DMR procedure may help to improve blood sugar control, insulin resistance (the
ability of cells to respond to insulin), and overall control of diabetes. It may also help to reduce a build-up of fat in the liver that occurs in some people with diabetes.
A small study of DMR treatment for people on insulin showed similar improvements in diabetes and that some participants were able to manage their diabetes without insulin following the procedure.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0787
Date of REC Opinion
28 Feb 2023
REC opinion
Further Information Favourable Opinion