Multicentric Prospective Randomized Trial on Surgery Versus Standard Medical Care in Type 2 Diabetic Patients BMI 30-35

Summary

200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery (biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical treatment.

Subjects will be monitored during a 5 year period to assess the effects of the surgical procedures on diabetes resolution and control at 1, 3 and 5 years.

Conditions

• Diabetes Mellitus

Interventions

PROCEDURE

Bariatric surgery

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

Sponsors & Collaborators

• Ospedale di Desenzano del Garda

  collaborator UNKNOWN

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• Azienda Ospedaliera Santa Maria Degli Angeli

  collaborator OTHER

• IRCCS Multimedica

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• Humanitas Gavazzeni di Bergamo

  collaborator UNKNOWN

• Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti

  collaborator OTHER

• Ente Ospedaliero Ospedali Galliera

  collaborator OTHER

• Ospedale S. Giovanni Bosco

  collaborator OTHER

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• University of Rome Tor Vergata

  collaborator OTHER

• Azienda Ospedaliera San Giovanni Battista

  collaborator OTHER

• Ospedale S. Timoteo, Termoli

  collaborator UNKNOWN

• Ospedale Marino, Cagliari

  collaborator UNKNOWN

• Hospital San Pietro Fatebenefratelli

  collaborator OTHER

• Azienda Ospedaliera Universitaria Policlinico

  collaborator OTHER

• Azienda ospedaliera Garibaldi Catania

  collaborator UNKNOWN

• IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

  lead OTHER

Principal Investigators

• Nicola Scopinaro, MD · Azienda Ospedaliera Universitaria "San Martino", Genova, Italy

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

35 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-03-31

Primary Completion

2010-12-31

Completion

2015-12-31

Countries

• Italy

Study Locations