Multicentric Prospective Randomized Trial on Surgery Versus Standard Medical Care in Type 2 Diabetic Patients BMI 30-35 (DIA-CHIR-MULT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2009 by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor:
Collaborators:
Ospedale di Desenzano del Garda
Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliera Santa Maria degli Angeli Pordenone
IRCCS Multimedica
Istituto Clinico Humanitas
Humanitas Gavazzeni di Bergamo
ASL Lanciano,Vasto
Ente Ospedaliero Ospedali Galliera
Ospedale S. Giovanni Bosco
Policlinico Gemelli, Roma
Policlinico Tor Vergata, Roma
Azienda Ospedaliera San Giovanni Battista
Ospedale S. Timoteo, Termoli
Ospedale Marino, Cagliari
Hospital San Pietro Fatebenefratelli
Azienda Ospedaliera Universitaria Policlinico
Azienda ospedaliera Garibaldi Catania
Information provided by:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT01041768
First received: December 31, 2009
Last updated: March 29, 2010
Last verified: December 2009

December 31, 2009
March 29, 2010
March 2009
December 2010   (final data collection date for primary outcome measure)
Proportion of patients achieving diabetes complete remission (HbA1c 6% or below) or diabetes control (HbA1c between 7% and 6.1%) on free diet and with no antidiabetic medical therapy. [ Time Frame: year 1, 3, 5 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01041768 on ClinicalTrials.gov Archive Site
Stable reduction of preoperative HbA1c; BMI; mortality/morbidity; Major components of the metabolic syndrome; Diabetes complications; Improvement of beta-cell function; insulin resistance reduction ; Overall and CV disease mortality. [ Time Frame: at and post surgery, 1,3, 5 years since randomization ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Multicentric Prospective Randomized Trial on Surgery Versus Standard Medical Care in Type 2 Diabetic Patients BMI 30-35
Multicentric Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Bilopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI Between 30 and 35

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.

The study is a multicentric prospective 2-arm randomized controlled trial. Only Centers with at least 50 bariatric surgeries performed during the time window January 2007 and September 2008 will be allowed to participate in the study.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
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
Other Names:
  • biliopancreatic diversion
  • gastric bypass
  • Active Comparator: antidiabetic medical therapy
    Intervention: Procedure: Bariatric surgery
  • Experimental: Bariatric Surgery
    Intervention: Procedure: Bariatric surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2015
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • BMI ≥30 and ≤34.9 kg/m2
  • 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:

  • specific contraindication to obesity surgery or GBP or BPD, including any gastric alteration specifically contraindicating GBP
  • 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
Both
35 Years to 70 Years
No
Contact: Nicola Scopinaro, MD +39 010 3537301 nicola.scopinaro@unige.it
Italy
 
NCT01041768
DIA-CHIR-MULT-BMI 30-35
Yes
Nicola Scopinaro, Prof., Azienda Ospedaliera Universitaria "San Martino"
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • Ospedale di Desenzano del Garda
  • Azienda Ospedaliero, Universitaria Pisana
  • Azienda Ospedaliera Santa Maria degli Angeli Pordenone
  • IRCCS Multimedica
  • Istituto Clinico Humanitas
  • Humanitas Gavazzeni di Bergamo
  • ASL Lanciano,Vasto
  • Ente Ospedaliero Ospedali Galliera
  • Ospedale S. Giovanni Bosco
  • Policlinico Gemelli, Roma
  • Policlinico Tor Vergata, Roma
  • Azienda Ospedaliera San Giovanni Battista
  • Ospedale S. Timoteo, Termoli
  • Ospedale Marino, Cagliari
  • Hospital San Pietro Fatebenefratelli
  • Azienda Ospedaliera Universitaria Policlinico
  • Azienda ospedaliera Garibaldi Catania
Principal Investigator: Nicola Scopinaro, MD Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP