Recruiting

Testing a stomach liner to help control type 2 diabetes and weight

Plain-English translation of NCT04101669 on ClinicalTrials.gov ↗ · Source last updated July 2024 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing the RESET System, a special liner that is placed inside your stomach during a routine endoscopy procedure to help improve blood sugar control in people with type 2 diabetes who haven't responded well enough to diabetes medications alone. The study will compare people who receive the RESET Liner with people who receive an endoscopy but without the liner. All participants will also receive lifestyle and dietary counseling to support their diabetes management.

Many people with type 2 diabetes take multiple medications but still struggle to achieve good blood sugar control. This trial is testing whether this new treatment could offer an additional option for people whose diabetes isn't well controlled with medication alone.

Do you qualify?

You likely qualify if…

you are between 22 and 65 years old
you have been diagnosed with type 2 diabetes and have a blood sugar (HbA1c) level between 7.5% and 10%
you have a body mass index (BMI) between 30 and 50
you have been taking at least two different diabetes medications at stable doses for at least 3 months but still haven't achieved good blood sugar control
you are willing to follow study requirements and attend visits regularly
if you are a woman of childbearing age, you are not pregnant and willing to use birth control during the trial

You likely don't qualify if…

you have had previous stomach or bowel surgery that could affect the placement or function of the liner
you have severe liver disease, kidney disease (low eGFR), or a history of serious abdominal infections requiring hospitalization
you have type 1 diabetes or a history of diabetic ketoacidosis
you have uncontrolled bleeding problems, severe vitamin D deficiency, or active acid reflux disease requiring certain medications
you have a history of pancreatitis, bone loss (osteopenia or osteoporosis), or an autoimmune connective tissue disease

What participation looks like

If you are selected for the trial, you will either receive the RESET Liner placed in your stomach during an endoscopy procedure (Arm 1) or have an endoscopy without the liner placed (Arm 2). Both groups will receive lifestyle and dietary counseling along with their regular diabetes medications. You will have follow-up visits to monitor your blood sugar, health, and any side effects. The trial aims to enroll 264 people total and is currently recruiting participants.

AI-generated summary from trial data · Jun 7, 2026 · Not medical advice

Trial locations(7 sites)

United States

MedStar Health Research Institute, Washington D.C., District of Columbia

University of Miami Hospital, Miami, Florida

Brigham and Women's Hospital, Boston, Massachusetts

Michigan Medicine, Division of Gastroenterology and Hepatology, Ann Arbor, Michigan

Weill Cornell Medicine, New York, New York