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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

Age ≥30 years and ≤ 65 years

Diagnosis of type 2 diabetes for ≤ 15 years

Timeline

Screening 1 weeks

Treatment 24 months

Follow Up 4 weeks

Awards & highlights

STEP-1 Trial Summary

This trial will study the EndoBarrier System, a tube that goes down the throat and into the stomach, in people with type 2 diabetes and obesity who are not able to control their blood sugar levels with diet and lifestyle changes or medication. The trial will compare the EndoBarrier System plus diet and lifestyle changes to diet and lifestyle changes alone to see if the EndoBarrier System is safe and effective.

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 8.0% and 10%, BMI between 30 and 50, not on insulin but have been on other diabetes meds without adequate control. Women must use birth control to prevent pregnancy during the trial.Check my eligibility

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.See study design

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.

STEP-1 Trial Eligibility Criteria

Inclusion Criteria

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

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I am between 30 and 65 years old.

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I have been diagnosed with type 2 diabetes for 15 years or less.

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I am not using insulin.

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Your HbA1c level is between 8.0% and 10%.

STEP-1 Trial Timeline

Screening ~ 1 weeks1 visit

Treatment ~ 24 months18 visits

Follow Up ~ 4 weeks18 visits

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in HbA1c

Secondary outcome measures

Blood pressure

Change in Nonalcoholic Fatty Liver Disease (NAFLD)

Change in Nonalcoholic Steatohepatitis (NASH)

+10 more

STEP-1 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

0 / 4Eligibility criteria met

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:

A review of medical history
Measuring of weight
Lab draw
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:

Weight
Waist and hip measurements
Questions about current medical issues
Lab draw
Urine sample
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

1 Previous Clinical Trials

288 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being sought for this investigation?

"Affirmative. According to clinicaltrials.gov, this medical experiment was initially posted on September 9th 2019 and is still actively enrolling patients. 240 individuals are necessary for the trial's completion across 6 distinct locations."

Answered by AI

Are participants under 85 years old being included for the research study?

"This clinical trial is exclusively seeking patients between 30 and 65 years old. Conversely, there are 249 trials targeting those under 18, and 1328 designed for persons over the age of 65."

Answered by AI

What is the total number of participants in this clinical trial?

"In order for the trial to be completed, 240 candidates meeting its criteria must enroll. GI Dynamics is overseeing this research and utilizing clinical sites such as Brigham and Women's Hospital in Boston, Massachusetts and MedStar Health Research Institute in Washington D.C."

Answered by AI

How many medical locations are hosting this examination in the state?

"Currently, 6 clinical trial sites are taking on new patient participants. These locations include Boston, Washington and Ann Arbor along with 3 other cities. To reduce travel needs during the study's duration, it is advised to select a site close to your residence if possible."

Answered by AI

Is it possible to register for this clinical trial?

"This trial is searching for an aggregate of 240 individuals aged between 30 and 65 years old who are affected by obesity. To be eligible, the potential study participants must satisfy the following stipulations: Be ≥30 to ≤65 years in age; understand and sign a legally binding consent agreement; possess a diagnosis of type 2 diabetes that has been present for no more than 15 years; HbA1c levels ranging from 8.0% to 10%; BMI values falling within the range of 30 kg/m2 - 50kg/m2; demonstrate compliance with all requirements set forth by this medical experiment along with providing one year's worth of"

Answered by AI