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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
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Procedure: Bariatric surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: March 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: antidiabetic medical therapy 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
Experimental: Bariatric Surgery 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041768

Contacts
Contact: Nicola Scopinaro, MD +39 010 3537301 nicola.scopinaro@unige.it

Locations
Italy
Azienda Ospedaliera Universitaria "San Martino" Recruiting
Genova, Italy, 15067
Contact: Nicola Scopinaro, MD    +39 010 3537301    nicola.scopinaro@unige.it   
Principal Investigator: Nicola Scopinaro, MD         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Nicola Scopinaro, MD Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
  More Information

No publications provided

Responsible Party: Nicola Scopinaro, Prof., Azienda Ospedaliera Universitaria "San Martino"
ClinicalTrials.gov Identifier: NCT01041768     History of Changes
Other Study ID Numbers: DIA-CHIR-MULT-BMI 30-35
Study First Received: December 31, 2009
Last Updated: March 29, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014