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Procedure

EndoBarrier Liner for Weight Loss (STEP-1 Trial)

Verified Trial
N/A
Recruiting
Led By Christopher C Thompson, MD
Research Sponsored by GI Dynamics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have you been diagnosed with Type 2 diabetes?
Are you currently taking at least two medications to manage your diabetes?
Timeline
Screening 1 weeks
Treatment 24 months
Follow Up 4 weeks
Awards & highlights

Summary

This trial is testing the EndoBarrier 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 EndoBarrier System has been shown to help with weight loss and better blood sugar control in patients with type 2 diabetes.

Who is the study for?
This trial is for adults aged 30-65 with type 2 diabetes for less than 15 years, 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.
What is being tested?
The EndoBarrier 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.
What are the potential side effects?
While specific side effects are not listed here, interventions like the EndoBarrier may cause gastrointestinal discomfort or complications, nutritional deficiencies due to malabsorption, or potential issues at the implant site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 1 weeks
Treatment ~ 24 months
Follow Up ~4 weeks
This trial's timeline: 1 weeks for screening, 24 months for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HbA1c
Secondary study objectives
Blood pressure
Change in Nonalcoholic Fatty Liver Disease (NAFLD)
Change in Nonalcoholic Steatohepatitis (NASH)
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EndoBarrierExperimental Treatment1 Intervention
Patients in ARM 1, will receive an upper endoscopy and will be treated with the EndoBarrier Liner
Group II: ShamPlacebo Group1 Intervention
Patients in Arm 2 will receive an upper endoscopy, but will not be treated with the EndoBarrier Liner.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EndoBarrier Liner
2010
N/A
~30

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for obesity, such as the EndoBarrier System, work by creating a physical barrier between food and the intestinal wall, which delays nutrient absorption and promotes weight loss and glycemic control. This mechanism is crucial for obesity patients as it helps reduce caloric intake and improves metabolic parameters, leading to better weight management and reduced risk of obesity-related complications. Other treatments, like GLP-1 receptor agonists, enhance satiety and slow gastric emptying, further aiding in weight loss and glycemic control. These approaches are significant as they address both the physical and hormonal aspects of obesity, providing a comprehensive strategy for managing the condition.
Can medical therapy mimic the clinical efficacy or physiological effects of bariatric surgery?Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes.

Find a Location

Screening: Screening visits will take 2 hours. During the screening visit, the trial will be reviewed by the study team and patients will be asked to sign a consent form if their questions have been answered and they would like to move forward with participating in the trial. Screening visits include:

  1. A review of medical history
  2. Measuring of weight
  3. Lab draw
  4. Urine and stool samples

Intervention: This is a double-blinded device study. Patients will be randomized on the day of the procedure and will undergo an endoscopy. Patients will not know which group they have been randomized to until the one year mark.

Follow-Up: Patients will be followed for a total of 2 years for this study. Follow-ups occur monthly for the first year and quarterly for the second year. Each study visit includes:

  1. Weight
  2. Waist and hip measurements
  3. Questions about current medical issues
  4. Lab draw
  5. Urine sample
  6. Ultrasound

The sponsor will compensate patients $50 per visit, up to $1,150 for the duration of the study if all visits are completed, to cover the cost of travel and parking.

Logistics

Travel, including flights, are covered

Your expenses for travel tickets for this trial will be reimbursed.

Who is running the clinical trial?

GI DynamicsLead Sponsor
15 Previous Clinical Trials
1,993 Total Patients Enrolled
10 Trials studying Obesity
1,807 Patients Enrolled for Obesity
Biostatistical Consulting, Inc.OTHER
2 Previous Clinical Trials
531 Total Patients Enrolled
Christopher C Thompson, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
308 Total Patients Enrolled
1 Trials studying Obesity
288 Patients Enrolled for Obesity

Media Library

EndoBarrier Liner (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04101669 — N/A
Obesity Research Study Groups: Sham, EndoBarrier
Obesity Clinical Trial 2023: EndoBarrier Liner Highlights & Side Effects. Trial Name: NCT04101669 — N/A
EndoBarrier Liner (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04101669 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT04101669 — N/A
~40 spots leftby Sep 2025
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