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Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion (DIA-BPD 25-30)

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ClinicalTrials.gov Identifier: NCT01046994
Recruitment Status : Unknown
Verified January 2010 by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
Recruitment status was:  Recruiting
First Posted : January 12, 2010
Last Update Posted : January 12, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Bariatric Surgery Biliopancreatic Diversion Procedure: biliopancreatic diversion Drug: antidiabetics Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
Study Start Date : July 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: surgery
biliopancreatic diversion
Procedure: biliopancreatic diversion
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
Active Comparator: standard medical care
patients treated according to the rules of good clinical practice
Drug: antidiabetics
patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice


Outcome Measures

Primary Outcome Measures :
  1. Diabetes control as defined by FSG and HbA1c [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Diabetes control as defined by FSG and HbA1c [ Time Frame: 5 years ]
  2. Assessment of prevalence and severity of diabetes complications [ Time Frame: 5 years ]
  3. Assessment of patient BMI [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age: 35-70 years
  • diabetes duration: >5 years
  • documented poor glycemic control (HbA1c =>8% despite medical treatment according to GCP)
  • presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
  • availability to comply with the entire follow-up

Exclusion Criteria:

  • general contraindications to BPD (applies also to medical controls)
  • presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration <0.5 mcg/L
  • blindness
  • severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
  • heart failure
  • recent history (less than 12 months) of myocardial infarction, stroke or TIA
  • unstable angina
  • pregnancy
  • previous or concomitant malignancy
  • severe active inflammatory, neurologic, or cardiovascular conditions
  • geographic inaccessibility
  • any condition which, in the opinion of the Principal Investigator, may make risky the participation in the study or bias the results
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046994


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

Locations
Italy
Ospedale San Martino Recruiting
Genova, Italy, 16132
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
Santa Chiara Hospital
Istituto Nazionale per lo Studio e la Cura dei Tumori
More Information

Responsible Party: Nicola Scopinaro, Professor of Surgery, Azienda Ospedaliera Universitaria San Martino
ClinicalTrials.gov Identifier: NCT01046994     History of Changes
Other Study ID Numbers: DIA-BPD
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: January 12, 2010
Last Verified: January 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs