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

Diabetes Mellitus Clinical Trial

— DIA-CHIR-MULT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01041768
• Other study ID #: DIA-CHIR-MULT-BMI 30-35
• Status: Recruiting
• Phase: N/A
• First received: December 31, 2009
• Last updated: March 29, 2010
• Start date: March 2009
• Est. completion date: December 2015

Study information

• Verified date: December 2009
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: Nicola Scopinaro, MD
• Phone: +39 010 3537301
• Email: nicola.scopinaro[@]unige.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria "San Martino"	Genova

Sponsors (18)

Lead Sponsor

Collaborator

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

Azienda ospedaliera Garibaldi Catania, Azienda Ospedaliera San Giovanni Battista, Azienda Ospedaliera Santa Maria Degli Angeli, Azienda Ospedaliera Universitaria Policlinico, Azienda Ospedaliero, Universitaria Pisana, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti, Ente Ospedaliero Ospedali Galliera, Hospital San Pietro Fatebenefratelli, Humanitas Gavazzeni di Bergamo, IRCCS Multimedica, Istituto Clinico Humanitas, Ospedale di Desenzano del Garda, Ospedale Marino, Cagliari, Ospedale S. Giovanni Bosco, Ospedale S. Timoteo, Termoli, Policlinico Universitario Agostino Gemelli, University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		year 1, 3, 5	Yes
Secondary	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.		at and post surgery, 1,3, 5 years since randomization	Yes