A clinical trial to study the Effect of EndoBarrier® in patients with Type 2 Diabetes and Obesity in India
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2022/06/043201
- Lead Sponsor
- GI Dynamics Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age =25 years and = 60 years
2. Have signed an informed consent form
3. Durations of type 2 diabetes for = 15 years
4. HbA1c = 8.0% and = 11%
5. BMI = 25 kg/m2 and < 50kg/m2
6. Willing and able to comply with study requirements
7. Documented negative pregnancy test in women of childbearing potential
8. Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on one reliable form of contraception to prevent unwanted pregnancies
9. At least one year of medical history available, including detailed medical therapy and dosing information
10. Failed to achieve adequate HbA1c reduction after dual therapy for at least 3-month stable dosage of oral anti-diabetes medication(s), including metformin, and one or more of the following: SGLT-2 inhibitor, GLP-1 RA or, meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.
11. Patients will discontinue Sulfonylureas 7 days prior to implant procedure.
1. Previous treatment with the EndoBarrier System
2. Previous GI surgery that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner, or abnormal GI anatomical finding that could preclude the ability to place the EndoBarrier Liner or affect the function of the EndoBarrier Liner
3. Known history of liver disease (e.g., viral, autoimmune, fibrosis/cirrhosis etiology, but not including incidental fatty liver)
4. Prior history of any hepatic abscess, or of any abscess requiring hospitalization, intravenous antibiotics or drainage.
5. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
6. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
7. Fasting C-peptide < 1.0 ng/mL
8. Triglyceride level > 600 mg/dL
9. Uncorrected Vitamin D deficiency ( <30ng/ml)
10. Male patients with serum creatinine (Cr) >1.5 mg/dl or female patients with Cr >1.4 mg/dl
11. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
12. Height < 5 feet (152.4 cm)
13. Current or past alcohol addiction, current or past drug addiction, or current drug usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
14. History of pancreatitis
15. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
16. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD)
17. Thyroid disease unless controlled with medication
18. 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-implant procedure
19. Currently taking the following medications (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:
Restricted Medications/Supplements
Systemic corticosteroids
Proton Pump Inhibitor (PPI)
Drugs known to affect GI motility (e.g. Metoclopramide)
Prescription or over-the-counter weight loss medication(s)
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), aspirin, ibuprofen, and other anti-inflammatory medication for study duration
Medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
Supplements that are known or suspected to increase bleeding risk including but not limited to:
Gingko biloba
Ginseng
Vitamins C & E
Turmeric
St. John’s wort
Evening primrose oil
Feverfew
Green Tea Extract
20. Allergy or hypersensitivity to cephalosporins or penicillin and all equivalent antibiotics
21. Active ulcer disease.
22. History of Crohn’s disease, atresias or untreated stenoses
28. Unintentional weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
29. Positive Fecal Immunochemical Test (FIT) at time of screening
30. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan <br/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method