- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973960
A Pilot Trial of the EndoBarrier™ Flow Restrictor for Glycemic Improvement in Type 2 Diabetics
August 5, 2011 updated by: GI Dynamics
The main objective of the study is to demonstrate the safety and efficacy of the EndoBarrier Flow Restrictor in the glycemic control of diabetes in subjects with Type 2 diabetes.
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
50
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
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Santiago, Chile
- Hospital Universidad Catolica
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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 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with Type 2 Diabetes
Description
Inclusion Criteria:
- Age > 18 years and < 55 years - Male or Female
- BMI > 30 BMI <60
- Subjects with an HbA1c > 7.5 and ≤ 10.0%
- Subjects with Type 2 diabetes who have been treated for ≤10 years
- Subjects on Metformin and/or Sulfonylurea
- History of failure with nonsurgical weight loss methods
- Subjects willing to comply with trial requirements
- Subjects who have signed an informed consent form
- Women who are post-menopausal, surgically sterile or on oral contraceptives and who do not plan on becoming pregnant during the course of the trial.
Exclusion Criteria:
- Treatment represents an unreasonable risk to the subject
- Subjects on oral diabetic medications other than Metformin or Sulfonylurea
- Subjects on insulin
- Subjects diagnosed with Type 1 Diabetes Mellitus or having a history of ketoacidosis
- Subjects with a past medical history of hypoglycemia
- Subjects with abnormal gastric emptying at baseline, defined as < 90% stomach emptied at 4 hours
- Subjects with a weight loss of > 4.5 Kg (10 lbs) within the 12 Weeks of screening
- Subjects taking corticosteroids or drugs known to affect GI motility (i.e. Reglan)
- Pregnant or have intention of becoming pregnant for the duration of the trial
- Unresolved alcohol or drug addiction
- Subjects receiving weight loss medications (prescription, over-the-counter, or herbal dietary medications)
- Previous gastrointestinal surgery that could affect the ability to place the EndoBarrier Flow Restrictor or the function of the implant.
- Subjects with active and uncontrolled GERD
- Subjects with symptomatic kidney stones prior to implant
- Subjects with iron deficiency and/or iron deficiency anemia
- History of Inflammatory bowel disease or condition of the gastrointestinal tract, such as ulcers or Crohn's disease
- Subjects with symptomatic gallstones prior to implant
- Symptomatic coronary artery disease or pulmonary dysfunction
- Known infection (Subjects who have a known infection at time of screening can be enrolled if the infection is treated prior to their procedure; if they still have an infection on day of procedure they must be withdrawn)
- History of congenital or acquired anomalies of the gastrointestinal tract such as atresias or stenoses
- Pancreatitis or other serious organic conditions
- Subjects requiring prescription anticoagulation therapy
- Subjects unable to discontinue NSAIDs (non-steroidal anti-inflammatory drugs) during the implant period
- Subject or Family history of a known diagnosis or pre-existing symptoms of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
- Participating in another ongoing investigational clinical trial
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics requiring medication that affects appetite (i.e. tricyclic antidepressants and atypical antipsychotic medications) which, in the opinion of the Investigator, makes the subject a poor candidate for device placement or clinical trial.
- Subjects with active H. pylori (Note: Subjects may be enrolled if they had a prior history of H. Pylori and were successfully treated or are diagnosed during baseline tests and undergo successful treatment before their procedure)
- Subjects with or a history of coagulopathy, upper gastro-intestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary efficacy endpoint is an assessment of glycemic control at week 24 or last assessment measured via HbA1c.
Time Frame: 24 weeks
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24 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The safety endpoint will be the incidence and severity of anticipated and unanticipated adverse events (device and non-device related).
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alex Escalona, MD, Hospital Universidad Catolica
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
September 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 6, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
August 8, 2011
Last Update Submitted That Met QC Criteria
August 5, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 09-2
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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