EndoBarrier Liner for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Weight Loss+3 MoreEndoBarrier Liner - Device
Eligibility
30 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Weight Loss
  • Endoscopy
  • Obesity
  • Diabetes Type 2

Treatment Effectiveness

Study Objectives

To determine if the EndoBarrier System significantly improves glycemic control; to determine if the EndoBarrier System can be safely used to improve glycemic control.

1 and 2 years
Blood pressure
Change in Nonalcoholic Fatty Liver Disease (NAFLD)
Change in Nonalcoholic Steatohepatitis (NASH)
Change in Risk Level of CKD albumin
Change in Risk Level of CKD eGFR
Change in daily fasting glucose level
Disease
HOMA-IR
HbA1c value
Insulin
LDL cholesterol
Lower risk of CKD progression
Lower risk of development of CKD
Questionnaire
Triglycerides
Weight Loss
One year
Change in HbA1c

Trial Safety

Trial Design

2 Treatment Groups

EndoBarrier
1 of 2
Sham
1 of 2

Experimental Treatment

Non-Treatment Group

240 patients who will be double-blinded and randomized to two arms of the trial in the ratio of 3 patients (Endobarrier) and 1 patient (Sham)

Primary Treatment: EndoBarrier Liner · Has Placebo Group · N/A

EndoBarrier
Device
Experimental Group · 1 Intervention: EndoBarrier Liner · Intervention Types: Device
Sham
Other
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EndoBarrier Liner
2010
N/A
~30

Trial Logistics

Trial Timeline

Screening: 2 hours
Treatment: Varies
Reporting: 1 and 2 years

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.

Who is running the clinical trial?

GI DynamicsLead Sponsor
15 Previous Clinical Trials
1,993 Total Patients Enrolled
4 Trials studying Weight Loss
167 Patients Enrolled for Weight Loss
Biostatistical Consulting, Inc.OTHER
2 Previous Clinical Trials
333 Total Patients Enrolled
Christopher C Thompson, MDPrincipal InvestigatorBrigham and Women's Hospital
1 Previous Clinical Trials
288 Total Patients Enrolled

Eligibility Criteria

Age 30 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have type 2 diabetes for less than 15 years.
You have diabetes and your HbA1c is between 8.0% and 10%.

Who else is applying?

What state do they live in?
California36.8%
Texas15.8%
Indiana10.5%
Other36.8%
How old are they?
18 - 65100.0%
What site did they apply to?
Michigan Medicine, Division of Gastroenterology and Hepatology20.0%
Baylor College of Medicine60.0%
MedStar Health Research Institute20.0%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Baylor College of Medicine: < 48 hours
Average response time
  • < 2 Days
References