Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion (DIA-BPD 25-30)

• Diabetes control as defined by FSG and HbA1c [ Time Frame: 5 years ] [ Designated as safety issue: No ]
• Assessment of prevalence and severity of diabetes complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
• Assessment of patient BMI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

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.

• Type 2 Diabetes Mellitus
• Bariatric Surgery
• Biliopancreatic Diversion

• Procedure: biliopancreatic diversion
  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
• Drug: antidiabetics
  patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice

• Experimental: surgery
  biliopancreatic diversion
  Intervention: Procedure: biliopancreatic diversion
• Active Comparator: standard medical care
  patients treated according to the rules of good clinical practice
  Intervention: Drug: antidiabetics

Inclusion Criteria:

• age: 35-70 years
• diabetes duration: >5 years
• documented poor glycemic control (HbA1c =>8% despite medical treatment according to GCP)
• presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
• availability to comply with the entire follow-up

Exclusion Criteria:

• general contraindications to BPD (applies also to medical controls)
• presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration <0.5 mcg/L
• blindness
• severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
• heart failure
• recent history (less than 12 months) of myocardial infarction, stroke or TIA
• unstable angina
• pregnancy
• previous or concomitant malignancy
• severe active inflammatory, neurologic, or cardiovascular conditions
• geographic inaccessibility
• any condition which, in the opinion of the Principal Investigator, may make risky the participation in the study or bias the results

• Università di Pisa - Ospedale Santa Chiara
• Istituto Nazionale per lo Studio e la Cura dei Tumori