Surgical Treatment of Type 2 Diabetes Mellitus in Patients With BMI <35 kg/m2 (Italian Title: "La Terapia Chirurgica Del Diabete Mellito di Tipo 2 Nel Paziente Con BMI Inferiore a 35 kg/m2")
| Registry | NCT00996294 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 50 (Actual) |
| Sponsor | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy (Other) |
| Conditions | Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion, Gastric Bypass |
| Interventions | biliopancreatic diversion, gastric bypass (Procedure) |
| Dates | start 2007-11-01, primary completion 2009-10-01, completion 2013-10-01 (estimated), first posted 2009-10-16, last updated 2010-01-12 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Type 2 Diabetes Mellitus All trials for Bariatric Surgery All trials of biliopancreatic diversion, gastric bypass
Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| surgery | Experimental | Procedure: biliopancreatic diversion, gastric bypass | patients will be submitted to biliopancreatic diversion or gastric bypass |
Sex: All, ages: 35 Years to 70 Years
Inclusion Criteria: * Type 2 diabetes mellitus * Duration of diabetes ≥ 3 years * Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP) Exclusion Criteria: * Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass * Pregnancy * Medical conditions requiring acute hospitalisation * Severe diabetes complications or associated medical conditions \[such as blindness, end-stage renal failure (i.e. serum creatinine >2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)\] * Recent (within preceding 12 months) myocardial infarction, stroke or TIA * Unstable angina pectoris * Psychological conditions which may hamper patient's cooperation * Geographic inaccessibility * Any condition which, in the judgment of the Investigator, may make risky the participation in the study or bias the results
| Facility | City | Country | Status |
|---|---|---|---|
| Ospedale San Martino | Genova | Italy |