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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Procedure: Bariatric surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 15067
    • Recruiting
    • Azienda Ospedaliera Universitaria "San Martino"
    • Contact: Nicola Scopinaro, MD; Phone Number: +39 010 3537301; Email: nicola.scopinaro@unige.it
    • Principal Investigator: Nicola Scopinaro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: gastric bypass; biliopancreatic diversion
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: gastric bypass; biliopancreatic diversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Collaborators: Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliera Universitaria Policlinico; Azienda Ospedaliero, Universitaria Pisana; University of Rome Tor Vergata; Azienda Ospedaliera San Giovanni Battista; Istituto Clinico Humanitas; IRCCS Multimedica; Ente Ospedaliero Ospedali Galliera; Ospedale S. Giovanni Bosco; Azienda Ospedaliera Santa Maria Degli Angeli; Hospital San Pietro Fatebenefratelli; Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti; Ospedale di Desenzano del Garda; Humanitas Gavazzeni di Bergamo; Ospedale S. Timoteo, Termoli; Ospedale Marino, Cagliari; Azienda ospedaliera Garibaldi Catania

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: December 31, 2009
• First Submitted That Met QC Criteria: December 31, 2009
• First Posted (Estimate): January 1, 2010

Study Record Updates

• Last Update Posted (Estimate): March 30, 2010
• Last Update Submitted That Met QC Criteria: March 29, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: DIA-CHIR-MULT-BMI 30-35