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

NCT01041768 | Unknown DMC

• 1 other identifier: DIA-CHIR-MULT-BMI 30-35
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

antidiabetic medical therapy

ACTIVE COMPARATOR

Procedure: Bariatric surgery

Bariatric Surgery

EXPERIMENTAL

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

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

Also known as: biliopancreatic diversion, gastric bypass

Bariatric Surgery; antidiabetic medical therapy

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Azienda Ospedaliera Universitaria "San Martino"

Genova, 15067, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Bariatric Surgery; Biliopancreatic Diversion; Gastric Bypass

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Gastroenterostomy; Anastomosis, Surgical

Study Officials

• Nicola Scopinaro, MD

  Azienda Ospedaliera Universitaria "San Martino", Genova, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Scopinaro, MD

CONTACT

+39 010 3537301; nicola.scopinaro@unige.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 31, 2009
• First Posted: January 1, 2010
• Study Start: March 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2015
• Last Updated: March 30, 2010

Record last verified: 2009-12

Locations

IT (1)