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
284278
Contact name
David Hopkins
Contact email
Sponsor organisation
Fractyl Laboratories Inc
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 3 months, 13 days
Research summary
The 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.
Previous research has shown that the duodenum, part of the intestinal tract below the stomach, has an important role in the regulation of blood glucose and on the action of insulin in the body. It has been shown that the inner lining (called the mucosa) of this part of the gut is thickened in diabetes and that changes here may be important in the development of resistance to the action of the hormone insulin, one of the underlying factors that leads to the development of diabetes. It has also been shown that preventing food from reaching the duodenal mucosa or ablating the outer layer of the mucosa can improve glucose levels and insulin action. These observations have led to the development of the Revita system.The Revita technique applies heat to the duodenal mucosa in a controlled manner by passing hot water through a balloon placed in contact with the mucosa using an endoscope. The heat causes the surface layer of cells (known as the endothelium) to be shed from the duodenal mucosa. Following this procedure, the mucosa heals and reverts to the thickness and characteristics seen in people without diabetes. In previous studies the use of this technique has been shown to be associated with a significant improvement in blood glucose control in people with diabetes on tablet medication and with improvement in other measures of metabolic health, particularly in the fat content of the liver, which is often increased in diabetes.
This study aims to extend our understanding of the impact of duodenal mucosal resurfacing on people with diabetes by studying people later in the course of their diabetes who are already on insulin treatment. In particular the study aims to determine if the use of this technique can allow insulin treatment to be withdrawn and for the condition to be managed with tablets instead. To do this the study will use a ‘sham control’ design where half of the participants will have the Revita procedure performed and the other half will have a sham procedure which includes the endoscopy but does not involve the use of the heated balloon to treat the mucosa.REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0793
Date of REC Opinion
11 May 2022
REC opinion
Further Information Unfavourable Opinion