- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01114438
Post Marketing Study in Subjects Who Have Type 2 Diabetes Using the EndoBarrier™ Gastrointestinal Liner
April 21, 2017 updated by: GI Dynamics
The purpose of this study is to evaluate EndoBarrier Gastrointestinal Liner in the post marketing environment in subjects who are obese and have Type 2 Diabetes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks.
NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks.
GI Dynamics' EndoBarrier represents a viable alternative to other short-term pre-surgical weight loss methods.
EndoBarrier is a device that can be implanted and removed through minimal invasive endoscopic techniques.
This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- Imperial College/St. Mary's Hospital
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Manchester, United Kingdom
- Trafford General Hospital/NOSC
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Southampton, United Kingdom
- Southampton General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects Age > 18 years and ≤65 years - Male or Female
- Subjects with Type 2 Diabetes > 1 and ≤ 10 years in duration
- Subjects with an Hb A1c level > 7.5 and ≤ 10.0
- Subjects taking oral Type 2 Diabetes medications and/or insulin. Metformin is allowed, but not required.
- Subjects with a BMI > 30 and< 50
- Subjects willing to comply with study requirements
- Subjects who have signed an informed consent form
- Women who are post-menopausal, surgically sterile or on contraceptives and agree to remain on contraceptives for the duration of their study participation and agree not to become pregnant during the study.
Exclusion Criteria:
- Subjects taking Inhibitors of dipeptidyl peptidase 4 inhibitors (ie. Januvia (sitagliptin), Galvus (vildagliptin) or incretins (ie. Byetta (exenatide), Victoza (liraglutide)
Subjects requiring insulin >150 units per day
• Subjects with probable insulin production failure (fasting C Peptide serum <1.0 ng/mL)
- Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- Subjects requiring NSAIDs (non-steroidal anti-inflammatory drugs) or prescription anticoagulation therapy during the implant period
- Subjects with or a history of iron deficiency and/or iron deficiency anemia
- Subjects with or a history of abnormalities of the GI tract
- Subjects with symptomatic gallstones or kidney stones at the time of screening
- Subjects with a known infection
- Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
- Subjects mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical study participation
- Subjects with previous GI surgery that could affect the ability to place the device or the function of the implant
- Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated. If Subjects have active H. pylori at baseline, they can receive appropriate treatment and then subsequently enroll to the study.)
- Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Subjects with active and uncontrolled gastroesophageal reflux disease (GERD)
- Subjects with severe liver or kidney failure (serum creatinine >180mmol/l)
- Subjects with poor dentition who can not adequately chew their food
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Device
|
EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c (%) Measured at Week 52
Time Frame: 12 months
|
12 months
|
|
Total Weight Change From Baseline to Week 52
Time Frame: 12 months
|
Total weight change at 12 months (kg) compared to baseline
|
12 months
|
Changes in Diabetic Medications at Treatment Completion Compared to Baseline
Time Frame: 12 months
|
number of patients with a decrease, increase or no change in diabetic medications at time of EndoBarrier explantation (treatment completion)
|
12 months
|
Change From Baseline in SF 36v2 Quality of Life Assessment
Time Frame: Baseline, 12 months (explant), 6 months post explant (18 months post baseline)
|
Quality of life was measured using Survey Form SF-36v2 licensed from Quality Metric, Inc (Lincoln, RI).
Physical and Mental component scores were measured at baseline, month 12 (at the time of explant) and 6 months post explant with results self-recorded by each subject.
The SF-36 v2 physical component summary (PCS) score as well as the mental component summary score (MCS) ranged between 0 and 100, with higher scores reflecting better quality of life in each case.
|
Baseline, 12 months (explant), 6 months post explant (18 months post baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julian Teare, MD, Imperial College/St. Mary's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
April 29, 2010
First Submitted That Met QC Criteria
April 29, 2010
First Posted (Estimate)
May 3, 2010
Study Record Updates
Last Update Posted (Actual)
April 24, 2017
Last Update Submitted That Met QC Criteria
April 21, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual subject data is on file at the Sponsor
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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