Multicentric Prospective Randomized Trial on Surgery Versus Standard Medical Care in Type 2 Diabetic Patients BMI 30-35
NCT ID: NCT01041768
Last Updated: 2010-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2009-03-31
2015-12-31
Brief Summary
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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.
Detailed Description
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Each Collaborating Center participating in the study will perform only one type of surgical procedure (GBP or BPD), depending on which one it is more familiar with.
Patients will be randomly assigned with a 2 to 1 ratio to receive either bariatric surgery (BS) (either GBP or BPD) or standard antidiabetic care (AC). The randomization will be centralized in the Coordinating Center. Patients assigned to BS will undergo GBP or BPD, depending on each Collaborating Center. Recruitment will continue, independently of the number of recruited patients per center, until the target of 200 GBP+BPD patients, and 100 AC patients will be attained.
After one year since enrollment, patients in AC group will be offered the choice to undergo one of the two surgical procedures, and then will follow the same protocol study as the other surgical patients. In addition, each Collaborating Center will be responsible for selecting one diabetic subject for each operated patient, matched as closely as possible with the patients assigned to surgical therapy, from the local population in medical treatment. These patients will serve as controls for long term mortality and morbidity.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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antidiabetic medical therapy
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
Bariatric Surgery
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age between 35 and 70 years
* duration of diabetes ≥ 5 years
* poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
* presence of significant co-morbidities or complications (such as dyslipidemia, arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
Exclusion Criteria
* HbA1c \< 8%
* positive autoantibodies anti-pancreas islet
* serum C-peptide \< 0.5 ng/ml
* pregnancy
* medical conditions requiring acute hospitalisation
* severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure
* 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 judgement of the Investigator, may make risky the participation in the study or bias the results
35 Years
70 Years
ALL
No
Sponsors
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Ospedale di Desenzano del Garda
UNKNOWN
Azienda Ospedaliero, Universitaria Pisana
OTHER
Azienda Ospedaliera Santa Maria Degli Angeli
OTHER
IRCCS Multimedica
OTHER
Istituto Clinico Humanitas
OTHER
Humanitas Gavazzeni di Bergamo
UNKNOWN
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
OTHER
Ente Ospedaliero Ospedali Galliera
OTHER
Ospedale S. Giovanni Bosco
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
University of Rome Tor Vergata
OTHER
Azienda Ospedaliera San Giovanni Battista
OTHER
Ospedale S. Timoteo, Termoli
UNKNOWN
Ospedale Marino, Cagliari
UNKNOWN
Hospital San Pietro Fatebenefratelli
OTHER
Azienda Ospedaliera Universitaria Policlinico
OTHER
Azienda ospedaliera Garibaldi Catania
UNKNOWN
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
OTHER
Responsible Party
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Azienda Ospedaliera Universitaria "San Martino"
Principal Investigators
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Nicola Scopinaro, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
Locations
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Azienda Ospedaliera Universitaria "San Martino"
Genova, , Italy
Countries
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Central Contacts
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Facility Contacts
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Nicola Scopinaro, MD
Role: primary
Other Identifiers
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DIA-CHIR-MULT-BMI 30-35
Identifier Type: -
Identifier Source: org_study_id