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| Name | Class |
|---|---|
| Ospedale di Desenzano del Garda | UNKNOWN |
| Azienda Ospedaliero, Universitaria Pisana | OTHER |
| Azienda Ospedaliera Santa Maria Degli Angeli | OTHER |
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200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery (biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical treatment.
Subjects will be monitored during a 5 year period to assess the effects of the surgical procedures on diabetes resolution and control at 1, 3 and 5 years.
The study is a multicentric prospective 2-arm randomized controlled trial. Only Centers with at least 50 bariatric surgeries performed during the time window January 2007 and September 2008 will be allowed to participate in the study.
Each Collaborating Center participating in the study will perform only one type of surgical procedure (GBP or BPD), depending on which one it is more familiar with.
Patients will be randomly assigned with a 2 to 1 ratio to receive either bariatric surgery (BS) (either GBP or BPD) or standard antidiabetic care (AC). The randomization will be centralized in the Coordinating Center. Patients assigned to BS will undergo GBP or BPD, depending on each Collaborating Center. Recruitment will continue, independently of the number of recruited patients per center, until the target of 200 GBP+BPD patients, and 100 AC patients will be attained.
After one year since enrollment, patients in AC group will be offered the choice to undergo one of the two surgical procedures, and then will follow the same protocol study as the other surgical patients. In addition, each Collaborating Center will be responsible for selecting one diabetic subject for each operated patient, matched as closely as possible with the patients assigned to surgical therapy, from the local population in medical treatment. These patients will serve as controls for long term mortality and morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antidiabetic medical therapy | Active Comparator |
| |
| Bariatric Surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery | Procedure | Biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve; Gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving diabetes complete remission (HbA1c 6% or below) or diabetes control (HbA1c between 7% and 6.1%) on free diet and with no antidiabetic medical therapy. | year 1, 3, 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Stable reduction of preoperative HbA1c; BMI; mortality/morbidity; Major components of the metabolic syndrome; Diabetes complications; Improvement of beta-cell function; insulin resistance reduction ; Overall and CV disease mortality. | at and post surgery, 1,3, 5 years since randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Scopinaro, MD | Contact | +39 010 3537301 | nicola.scopinaro@unige.it |
| Name | Affiliation | Role |
|---|---|---|
| Nicola Scopinaro, MD | Azienda Ospedaliera Universitaria "San Martino", Genova, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera Universitaria "San Martino" | Recruiting | Genova | 15067 | Italy |
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| IRCCS Multimedica |
| OTHER |
| Istituto Clinico Humanitas | OTHER |
| Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo | UNKNOWN |
| Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti | OTHER |
| Ente Ospedaliero Ospedali Galliera | OTHER |
| Ospedale S. Giovanni Bosco | OTHER |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | OTHER |
| University of Rome Tor Vergata | OTHER |
| Azienda Ospedaliera San Giovanni Battista | OTHER |
| Ospedale S. Timoteo, Termoli | UNKNOWN |
| Ospedale Marino, Cagliari | UNKNOWN |
| Hospital San Pietro Fatebenefratelli | OTHER |
| Azienda Ospedaliera Universitaria Policlinico | OTHER |
| Azienda ospedaliera Garibaldi Catania | UNKNOWN |
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|
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D015904 | Biliopancreatic Diversion |
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D005763 | Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
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