RevitaT2Di Pivotal Study (REVITALIZE 1)

Study of a Duodenal Procedure for Adults With Type 2 Diabetes

Age
21 years - 70 years
Gender
All
participants needed
20
Location
1
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RevitaT2Di Pivotal Study (REVITALIZE 1)

Brief description of study

The Revitalize-1 Study will look at a potential procedure called duodenal mucosal resurfacing (DMR). The DMR procedure acts on the first layer (mucosa) of the duodenum (the part of the small intestine located immediately after the stomach). By removing an excess layer, the treatment may improve blood sugar control. This treatment may eliminate or reduce the need for insulin injections in the future for the treatment of Type 2 Diabetes.

Detailed description of study

Study participation will last for a total of 48-96 weeks. You will be compensated for participation in this study, and will not have to pay for any study procedures. In addition to receiving either the Revita™ DMR procedure or control procedure, you will diabetes medication counseling and will undergo the following medical procedures: routine blood work, EKG, MRI, fibroscan, and endoscopy.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Type 2 Diabetes
  • Age: 21 years - 70 years
  • Gender: All

You may be eligible for this study if:

1. You have Type 2 Diabetes
2. You are using insulin and take metformin to manage your diabetes
4. Your A1c is between 7.5% and 9.5%
5. Your BMI is between 24 and 40

The purpose of this research study is to learn about a procedure called duodenal mucosal resurfacing (DMR) for adults with type 2 diabetes who use insulin and metformin. DMR is done in the duodenum, which is the first part of the small intestine right after the stomach. The procedure removes an extra top layer of tissue in that area, which may improve blood sugar control.

Participants will receive either the DMR procedure or a control procedure. Participants will also receive counseling about diabetes medicines. During the study, participants will have routine blood work, an EKG (a test that checks heart rhythm), an MRI scan, a FibroScan (a scan that checks the liver), and an endoscopy (a procedure that uses a flexible tube to look inside the digestive tract). There is no cost for study procedures, and participants will be compensated for taking part.

Who can participate:
Adults with type 2 diabetes may be able to participate if they:

  • Use insulin and take metformin to manage their diabetes
  • Have an A1c between 7.5% and 9.5%
  • Have a BMI between 24 and 40

Study timeline and visits:
Participation lasts a total of 48–96 weeks.

Updated on 04 Aug 2024. Study ID: 849853

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