RESET Liner for Type-2 Diabetes and Obesity

(STEP-1 Trial)

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen by Christopher Thompson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Morphic Medical

Must be taking: Diabetes medications

Must not be taking: Corticosteroids, PPIs, NSAIDs, others

Disqualifiers: Liver disease, Type 1 diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the RESET System, a device placed in the stomach, to help people with Type 2 Diabetes and Obesity who haven't controlled their blood sugar well with current medications. The device works by reducing food absorption, aiding in better blood sugar control and weight loss. The RESET System has been shown to help with weight loss and better blood sugar control in patients with type 2 diabetes.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including systemic corticosteroids, proton pump inhibitors, drugs affecting GI motility, weight loss medications, NSAIDs, and some supplements known to increase bleeding risk. If you are currently taking any of these, you will need to stop before and during the trial.

What data supports the effectiveness of the EndoBarrier Liner treatment for Type 2 Diabetes?

Research shows that the EndoBarrier Liner, a type of duodenal-jejunal bypass liner, helps people with type 2 diabetes lose weight and improve their blood sugar control. Studies found that it significantly improved insulin sensitivity (how well the body uses insulin) and reduced body weight in obese individuals with type 2 diabetes. ^{1 2 3 4 5}

Is the EndoBarrier Liner safe for humans?

The EndoBarrier Liner has been studied in several trials, showing that it can cause side effects like abdominal pain, nausea, and vomiting, but no deaths were reported. More high-quality long-term studies are needed to fully understand its safety. ^{2 3 4 6 7}

How is the EndoBarrier Liner treatment different from other treatments for type 2 diabetes?

The EndoBarrier Liner is a unique treatment for type 2 diabetes because it is a sleeve that is placed inside the intestine to mimic the effects of gastric bypass surgery, helping with weight loss and improving insulin sensitivity without the need for surgery. It works by preventing food from coming into contact with the upper part of the intestine, which can lead to better blood sugar control. ^{2 3 4 5 7}

Research Team

Christopher Thompson, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults aged 22-65 with type 2 diabetes, HbA1c levels between 7.5% and 10%, BMI between 30 and 50, but have been on other diabetes meds without adequate control including insulin. Women must use birth control to prevent pregnancy during the trial.

Inclusion Criteria

Are you currently taking at least two medications to manage your diabetes?

Have you been diagnosed with Type 2 diabetes?

Is your HbA1c (a measure of blood sugar control) between 7.5% and 10%?

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the RESET System treatment or sham procedure along with moderate intensity lifestyle and dietary counseling

9 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 9 and 21 months

Treatment Details

Interventions

• EndoBarrier Liner (Procedure)
• Sham (Other)

Trial Overview The RESET System's effectiveness in improving blood sugar levels in patients with poorly controlled type 2 diabetes and obesity is being tested against a sham (fake) procedure, alongside lifestyle and dietary counseling based on ADA standards.

Participant Groups

Group I: RESET Experimental Treatment 1 Intervention

Patients in ARM 1, will receive an upper endoscopy and will be treated with the RESET Liner

Group II: Sham Placebo Group 1 Intervention

Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the RESET Liner.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Baylor College of Medicine Houston, TX

Cornell Medicine New York, NY

Cleveland Clinic Cleveland, OH

Weill Cornell Medicine New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

Morphic Medical

Lead Sponsor

Trials

1

Patients Recruited

260+

Morphic Medical Inc.

Lead Sponsor

Trials

16

Patients Recruited

2,300+

Biostatistical Consulting, Inc.

Collaborator

Trials

3

Patients Recruited

750+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of 6 and 12 months Duodenal-Jejunal Bypass Liner Treatment on Obesity and Type 2 Diabetes: a Crossover Cohort Study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Weight loss and metabolic improvement in morbidly obese subjects implanted for 1 year with an endoscopic duodenal-jejunal bypass liner. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effect of the EndoBarrier Device: a 4-Year Follow-up of a Multicenter Randomized Clinical Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Duodeno-Jejunal Bypass Liner (EndoBarrierTM) Implantation on Insulin Sensitivity in Patients with Type 2 Diabetes Mellitus (T2DM): A Study Protocol for a Pilot Trial. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

EndoBarrier™ Implantation Rapidly Improves Insulin Sensitivity in Obese Individuals with Type 2 Diabetes Mellitus. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: a systematic review and meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Role of proximal gut exclusion from food on glucose homeostasis in patients with Type 2 diabetes. [2022]