Status:
UNKNOWN
EndoBarrier Versus Intragastric Balloon in Obese Diabetic Patients
Lead Sponsor:
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Conditions:
Type 2 Diabetes
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
Obese patients with Type 2 diabetes (T2D) have a 80-98% chance of having their disease cured or improved following bariatric surgery. This could be explained by weight loss or by changes of nutrient a...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- Adults (18-60 year old)
- Type 2 Diabetes diagnosed less than 10 years ago
- Obesity (BMI \> 30)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01848795
Start Date
May 1 2013
End Date
May 1 2019
Last Update
March 24 2015
Active Locations (1)
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1
ISMETT
Palermo, Italy, Italy, 90127