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©2022 Stanford Medicine
Not Recruiting
Trial ID: NCT01728116
A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Comparing the EndoBarrier Gastrointestinal Liner System vs. Sham for Glycemic Improvement in Inadequately Controlled Obese Type 2 Diabetic Subjects on Oral Anti-Diabetes Agents
Clinical Associate Professor, Medicine - Endocrinology, Gerontology, & Metabolism
Inclusion Criteria:
- Males/females aged ≥ 21 years and ≤ 65 years
- Diagnosis of Type 2 Diabetes for ≤ 20 years
- Obese individuals (BMI ≥ 30 kg/m2 and ≤ 55 kg/m2)
- Stable doses (at least 3 months) of up to two anti-T2DM medications (MET, SU, DPP-4i
or TZD)
- Glycemic state: HbA1c at screening ≥ 7.5% and ≤ 10.0%.
- Subjects willing to comply with study requirements
- Subjects who have signed an informed consent form
Exclusion Criteria:
- Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
- C-peptide < 1.0 ng/mL
- Triglyceride level > 400 mg/dL
- Vitamin D deficiency (<20 ng/mL)
- Male subjects with serum Creatinine >1.5 mg/dl or female subjects with Creatinine >1.4
mg/dL
- Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet
count less than 100,000/microliter, or known coagulopathy
- Height < 5 feet (152.4 cm)
- Current alcohol or drug addiction
- Symptomatic kidney stones or gallstones within 6 months prior to randomization
- Chronic pancreatitis or acute pancreatitis within 12 months of randomization
- Diagnosis of osteoporosis or currently taking bisphosphonates or teriparatide
- Diagnosis of an autoimmune connective tissue disorder (e.g., lupus erythematosus,
scleroderma)
- Active gastroesophageal reflux disease [GERD] uncontrolled with a Proton Pump
Inhibitor (PPI)
- Thyroid disease unless controlled with medication
- Currently taking Non-Steroidal Anti-Inflammatory Drugs [NSAIDs] (e.g., aspirin,
ibuprofen, etc.) within 10 days prior to randomization and/or there is a need or
expected use of these agents during the trial 12 months post index procedure
- Currently taking prescription antithrombotic therapy (e.g., anticoagulant or
antiplatelet agent) within 10 days prior to randomization and/or there is a need or
expected need to use during the trial 12 months post index procedure
- Currently taking systemic corticosteroids, drugs known to affect GI motility,
prescription/over-the-counter weight loss medications, or medications known to cause
significant weight gain or weight loss within 30 days prior to randomization and/or
there is a need or expected need to use these medications during the trial 12 months
post index procedure
- Medication for type 2 diabetes other than MET, SU, DPP-4i, and TZD (e.g., GLP1 or
insulin) within 3 months of screening
- Chronic use of narcotics, opiates, benzodiazepines, or other addictive tranquilizers
- Allergy or hypersensitivity to ceftriaxone, cephalosporins, penicillin, or any
equivalent antibiotics
- Active Helicobacter pylori infection (Note: Subjects may be eligible after undergoing
2 weeks of antibiotic treatment without re-screening)
- Previous GI surgery or abnormal GI anatomical finding that could preclude the ability
to place the EndoBarrier device, liner or affect the function of the liner
- Abnormal pathologies or conditions of the gastrointestinal tract, including current
ulcers or Crohn's disease, history of atresias or untreated stenoses, current upper
gastrointestinal bleeding conditions within 3 months of randomization
- Any condition or major illness that places the subject at undue risk by participating
in the study
- Poor dentition not allowing complete chewing of food
- Enrolled in another investigational study within 3 months of screening for this study
(Enrollment in observational studies is permitted)
- Residing in a location without ready access to study site medical resources
- Documented weight loss of >10 pounds anytime during the 3 months preceding
randomization
- Positive stool guaiac at time of screening
device: EndoBarrier
procedure: Sham Procedure
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Elizabeth Colbert
650-723-3186