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Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese

Trial ID or NCT#

NCT01728116

Status

RECRUITING

Purpose

To determine if the EndoBarrier safely and effectively improves glycemic control in obese subjects with type 2 diabetes

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 21 Years to 65 Years

Sexes Eligible for Study: All

Accepts Healthy Volunteers: No

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

View All Criteria

Investigator(s)

Tracey McLaughlin

Endocrinologist

Professor of Medicine (Endocrinology) at the Stanford University Medical Center

Dr. John Magaña Morton

Bariatric surgeon, General surgeon, Minimally invasive surgeon

Associate Professor of Surgery (General Surgery) at the Stanford University Medical Center

Marilyn Tan, MD

Endocrinologist

Clinical Assistant Professor, Medicine - Endocrinology, Gerontology, & Metabolism

CONTACT

Elizabeth Colbert
(650) 723-3186

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View on ClinicalTrials.gov

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