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Search / Trial NCT01848795

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

Type 2 Diabetes Obesity Gastrointestinal Hormones Intestinal Bypass Endoscopy

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.

Locations

Palermo, , Italy

Patients applied

0 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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