Jonah Hoyt, BS
Clinical Research Coordinator
Jonah A. Hoyt B.S, Natasha Malkani M.D., Nabeeha A. Noor B.A, Grace S. Ordonez B.A, Lee-Shing Chang M.D., Pichamol Jirapinyo M.D., Alexander Turchin M.D., M.S., Chris C. Thompson M.D., Vanita R. Aroda M.D.
Vanita R. Aroda, MD
Research Category: Cardiovascular, Diabetes, and Metabolic Disorders
Background: Type 2 Diabetes Mellitus (T2DM) is a well-documented public health crisis, with adult diabetes prevalence estimated at 14.7% . The high incidence and burden of T2DM has led to renewed interest in developing novel glucose-lowering approaches. While many therapeutics address metabolic manifestations of diabetes, few address the proximal pathophysiologic factors underlying the progression of T2DM.
Objective: The objective of the REVITALIZE-1 study is to evaluate whether the endoscopic procedure Duodenal Mucosal Resurfacing (DMR) can reduce or eliminate insulin requirement in persons with T2DM treated with basal insulin.
Methods: The REVITALIZE-1 study is a prospective randomized, double-blind, sham-controlled, multi-center study (n=560) evaluating the efficacy and safety of DMR using the Revita® system in participants with T2DM on insulin therapy. DMR involves a mucosal lift and hydrothermal ablation of the duodenum from the ampulla of Vater to the ligament of Treitz. The primary outcome is the percentage of participants treated with the DMR procedure vs control who achieve an HbA1c of < 7.0% at 24 weeks without requiring insulin.
Conclusion: The REVITALIZE-1 study will determine the extent to which DMR can safely and effectively reduce the medication burden of T2DM and favorably alter its natural course.
T2DM treatment goals are person-centered, with the aim to prevent or delay complications and optimize quality of life . The high incidence , economic burden , and inherent risks of uncontrolled glycemia in T2DM, demonstrate the need for an innovative perspective regarding the treatment of T2DM.
The REVITALIZE-1 study is investigating duodenal mucosal resurfacing (DMR) as a procedural treatment for T2DM. This study aims to enroll 560 participants with T2DM inadequately controlled with insulin. Efficacy will be determined by the percentage of participants treated with DMR compared to control who achieve target glycemic goals without using insulin at 24 weeks.
REVITALIZE-1 will provide a comprehensive assessment of DMR as an investigational treatment of T2DM, potentially broadening future treatment options for persons with T2DM.