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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor:
Collaborators:
Università di Pisa - Ospedale Santa Chiara
Istituto Nazionale per lo Studio e la Cura dei Tumori
Information provided by:
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:
NCT01046994
First received: January 11, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 11, 2010
January 11, 2010
July 2009
December 2011   (final data collection date for primary outcome measure)
Diabetes control as defined by FSG and HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Diabetes control as defined by FSG and HbA1c [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assessment of prevalence and severity of diabetes complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Assessment of patient BMI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Bariatric 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
  • Drug: antidiabetics
    patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice
  • Experimental: surgery
    biliopancreatic diversion
    Intervention: Procedure: biliopancreatic diversion
  • Active Comparator: standard medical care
    patients treated according to the rules of good clinical practice
    Intervention: Drug: antidiabetics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2016
December 2011   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact: Nicola Scopinaro, MD +39 010 3537301 nicola.scopinaro@unige.it
Italy
 
NCT01046994
DIA-BPD
Yes
Nicola Scopinaro, Professor of Surgery, Azienda Ospedaliera Universitaria San Martino
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • Università di Pisa - Ospedale Santa Chiara
  • Istituto Nazionale per lo Studio e la Cura dei Tumori
Not Provided
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP