Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Santa Chiara Hospital | OTHER |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery | Experimental | biliopancreatic diversion |
|
| standard medical care | Active Comparator | patients treated according to the rules of good clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biliopancreatic diversion | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes control as defined by FSG and HbA1c | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes control as defined by FSG and HbA1c | 5 years | |
| Assessment of prevalence and severity of diabetes complications | 5 years | |
| Assessment of patient BMI |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Scopinaro, MD | Contact | +39 010 3537301 | nicola.scopinaro@unige.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Martino | Recruiting | Genova | 16132 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| antidiabetics | Drug | patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice |
|
| 5 years |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015904 | Biliopancreatic Diversion |
| D007004 | Hypoglycemic Agents |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided