REVITA-1 study

  • Research type

    Research Study

  • Full title

    Evaluation of Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Patients with Type 2 Diabetes

  • IRAS ID

    164394

  • Contact name

    Rehan Haidry

  • Contact email

    rehan.haidry@nhs.net

  • Sponsor organisation

    Fractyl

  • Duration of Study in the UK

    4 years, 5 months, 30 days

  • Research summary

    Type 2 Diabetes is an endocrine disorder linked to the obesity epidemic. It is characterized by chronically elevated blood glucose and subsequent vascular complications. The disease has spread rapidly in rich and poor nations and has been associated with increasing age, decreased physical activity and Western dietary habits. The current approach of medical therapy begins with improvements in diet and exercise but this is not enough in the vast majority of patients who require medication. Despite the availability of several different classes of medication, diabetes control will usually deteriorate requiring treatment with insulin. A large proportion of patients remain poorly controlled despite all of these measures.
    Recently, it has been noted that certain forms of bariatric surgery that divert the passage of nutrients around the duodenum (or first portion of the small intestine) appear to lead to nearly immediate and long-standing anti-diabetic effects irrelevant of weight change. A similar effect can be observed in type 2 diabetics with an endoscopically placed sleeve that prevents the interaction of food with the duodenum.

    The Duodenal resurfacing procedure (DMR) has been developed to safely and effectively ablate the duodenal mucosa in patients with type 2 diabetes. The objective is to alter the body’s hormonal response to food intake without the challenges associated with surgery or long-term gastrointestinal implants.

    The purpose of this study is to demonstrate the efficacy and safety of DMR for the treatment of uncontrolled type 2 diabetes at University College Hospital London.

    Following a 4-week medication run-in, an endoscopy with ablation of 9cm of duodenal mucosa will be compared with a sham procedure. Follow-up will occur at one month and a repeat endoscopy will be performed after 3 months where duodenal ablation will occur for the sham arm group. Further follow-up evaluations will take place regularly until 36 months.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    15/LO/0020

  • Date of REC Opinion

    10 Feb 2015

  • REC opinion

    Further Information Favourable Opinion