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Procedure for Inadequately Controlled Type 2 Diabetes Patients on Insulin Revitalize 1 Study

  • Study HIC#:2000029448
  • Last Updated:06/21/2022

The purpose of the REVITALIZE 1 Study is to learn more about an investigational procedure called duodenal mucosal resurfacing (DMR). The study will check if the DMR procedure can be safely used to reduce or eliminate the need for insulin in people with type 2 diabetes.

The DMR procedure uses an investigational device, called the Revita ® System. The Revita System works by heating the mucosa of the duodenum. The heating initiates a healing process to create a “new” healthier layer. It is thought that this new layer responds better to insulin. Studies have shown that this procedure can help to improve:

  • blood sugar control
  • insulin sensitivity
  • overall metabolic control

The DMR procedure is similar to an upper gastrointestinal (GI) endoscopy and is minimally invasive. You will be comfortably asleep during the procedure. The DMR procedure will last about 1 hour, and typically patients are able to go home the same day.

You, or someone you care for, may be able to take part if you/they:

  • Are 21–70 years of age
  • Have been diagnosed with type 2 diabetes
  • Are currently taking insulin

For More Information Please Contact:

Jackie Prinz

203-785-5977

diabetes.research@yale.edu

  • Age21 years - 70 years
  • GenderBoth
  • Start Date09/15/2021
  • End Date05/31/2023

Trial Purpose and Description

The purpose of the REVITALIZE 1 Study is to learn more about an investigational procedure called duodenal mucosal resurfacing (DMR). The study will check if the DMR procedure can be safely used to reduce or eliminate the need for insulin in people with type 2 diabetes.

The DMR procedure uses an investigational device, called the Revita ® System. The Revita System works by heating the mucosa of the duodenum. The heating initiates a healing process to create a “new” healthier layer. It is thought that this new layer responds better to insulin. Studies have shown that this procedure can help to improve:

  • blood sugar control
  • insulin sensitivity
  • overall metabolic control

The DMR procedure is similar to an upper gastrointestinal (GI) endoscopy and is minimally invasive. You will be comfortably asleep during the procedure. The DMR procedure will last about 1 hour, and typically patients are able to go home the same day.

You, or someone you care for, may be able to take part if you/they:

  • Are 21–70 years of age
  • Have been diagnosed with type 2 diabetes
  • Are currently taking insulin

For More Information Please Contact:

Jackie Prinz

203-785-5977

diabetes.research@yale.edu

Eligibility Criteria

Eligibility Criteria:

  • Age between 21 and 70 years (both inclusive)
  • Subjects with type 2 diabetes on stable doses of metformin (maximum tolerated dose) requiring insulin 20 units up to a maximum of 60 units 
  • Glycosylated Hemoglobin A1c (HbA1c) of 7.5-9.5%
  • FPG ≥180 to <270 mg/dl
  • Body Mass Index (BMI) ≥ 28 and ≤ 40 kg/m

For more information about this study, contact:

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