Study Details

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Medical Device Removing Excess Tissue in Digestive System in Individuals with Type 2 Diabetes on Insulin Therapy

The purpose of this research study is to learn more about the use of the Fractyl Revita System for the treatment of type 2 diabetes in patients who are on insulin therapy and certain other diabetes medications. The Revita System is a device that aids in removing excess tissue from the inner most layer of the small intestine, which is believed to play an important role in the control of type 2 diabetes. The procedure is expected to lead to an improvement in blood sugar control.

Age & Gender

21 years ~ 70 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

At the first visit, we will ask you to complete forms, questionnaires, undergo a physical exam, body measurements, and blood work. Visit 2 will include a medication review. Visit 3 will include an ECG, urine tests and imaging procedures to assess the health of your liver. Visit 4 you will undergo the duodenal mucosal resurfacing procedure. Following the procedure, you will be asked to follow a special diet for 14 days. From Day 15 following your procedure to the End of Study, you will be asked to check your blood glucose at least 2 times (fasting and before dinner).

Incentives

In-person visits:
10

Phone or online visits:
5

Total length of participation:
1-2 years

Looking for Specific Volunteers

Able to participate:

You have Type 2 Diabetes on stable dose of insulin, metformin, and up to 2 other diabetes medications
You have been told you are overweight or obese
You are between 21-70 years old
Your morning blood sugar is between 180 and 270
Your A1c is between 7.5% and 9.5%

Not eligible if:

You have Type 1 diabetes
You take meal-time insulin or a class of medication called sulphonylurea or SGLT2i
You experience frequent urinary tract infections
You have a history of chronic pancreatitis or a history of acute pancreatitis within the past year
You experience frequent episodes of low blood sugar or experience low blood sugar without realizing it

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Endocrinology Outpatient Center
UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Nicholas Shaheen
Medicine-Endocrinology

Study Type

Clinical or Medical
Interventional

Study Topics

Diabetes
Eating, Nutrition, and Metabolism
Wellness and Lifestyle
UNC or UNC Health employees

IRB Number

23-0413

ClinicalTrials.gov

NCT04419779