Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)
This trial is active, not recruiting.
|Conditions||type 2 diabetes mellitus, bariatric surgery, biliopancreatic diversion, gastric bypass|
|Treatment||biliopancreatic diversion, gastric bypass|
|Sponsor||IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy|
|Start date||November 2007|
|End date||October 2009|
|Trial size||50 participants|
|Trial identifier||NCT00996294, DIA-CHIR|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Diabetes control, define by FSG and HbA1c
time frame: 1 year
Diabetes control defined by FSG and HbA1c
time frame: 5 years
Male or female participants from 35 years up to 70 years old.
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
|Official title||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")|
|Principal investigator||Nicola Scopinaro, MD|
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