EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients
Launched by THE MEDITERRANEAN INSTITUTE FOR TRANSPLANTATION AND ADVANCED SPECIALIZED THERAPIES · May 3, 2013
Trial Information
Current as of August 21, 2025
Unknown status
Keywords
ClinConnect Summary
Bariatric surgery is an effective therapy for obesity. Malabsorption-based surgical techniques (excluding the first part of the gastrointestinal tract from the alimentary circuit) are also effective in correcting T2D, even before any significant weight loss has occurred. Proposed mechanisms to explain this beneficial effect include caloric restriction, altered secretion of gut hormones due to duodenal exclusion or due to contact of undigested food with the jejunal mucosa, pancreatic islet hyperfunction, changes of intestinal flora, mucosal inflammation, and/or changes in the biliary acid re...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults (18-60 year old)
- • Type 2 Diabetes diagnosed less than 10 years ago
- • Obesity (BMI \> 30)
- Exclusion Criteria:
- • pregnancy
- • inflammatory bowel disease
- • peptic ulcer
- • gastrointestinal disease preventing device positioning
- • pancreatitis,
- • coronary artery disease
- • symptomatic pulmonary disease
- • infection at the time of device placement,
- • high risk of gastrointestinal bleeding (coagulopathy, bleeding diathesis, anti-coagulant therapy, Non-Steroid Anti-Inflammatory Drugs)
- • altered GI anatomy that could affect device placement
- • contraindication of positioning of the devices as per technical description of the producer
- • C-peptide negative diabetes
- • failure to understand the study protocol or not willing to undergo planned follow-up
About The Mediterranean Institute For Transplantation And Advanced Specialized Therapies
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT) is a leading clinical research organization dedicated to advancing the fields of transplantation and specialized medical therapies. Situated in a state-of-the-art facility in Palermo, Italy, ISMETT combines innovative research with cutting-edge clinical practices to enhance patient outcomes and develop novel therapeutic strategies. The institute is committed to fostering collaboration among multidisciplinary teams of experts and leveraging its robust infrastructure to conduct high-quality clinical trials. Through its focus on scientific excellence and patient-centered care, ISMETT aims to contribute significantly to the fields of organ transplantation and advanced therapies on a global scale.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Palermo, , Italy
Patients applied
Trial Officials
Anna Casu, MD
Principal Investigator
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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