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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
patients will be submitted to biliopancreatic diversion or gastric bypass
biliopancreatic diversion, gastric bypass
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

Primary Outcomes

Diabetes control, define by FSG and HbA1c
time frame: 1 year

Secondary Outcomes

Diabetes control defined by FSG and HbA1c
time frame: 5 years

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.