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
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Bariatric Surgery
Biliopancreatic Diversion
Procedure: biliopancreatic diversion
Drug: antidiabetics
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:

Primary Outcome Measures:
  • Diabetes control as defined by FSG and HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: July 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Università di Pisa - Ospedale Santa Chiara
Istituto Nazionale per lo Studio e la Cura dei Tumori
  More Information

No publications provided

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
Study First Received: January 11, 2010
Last Updated: January 11, 2010
Health Authority: Italy: Comitato Etico dell'Azienda Ospedaliera Universitaria "San Martino"

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

ClinicalTrials.gov processed this record on September 16, 2014