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

Type 2 Diabetes Mellitus Clinical Trial

— DIA-BPD 25-30  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01046994
• Other study ID #: DIA-BPD
• Status: Recruiting
• Phase: Phase 3
• First received: January 11, 2010
• Last updated: January 11, 2010
• Start date: July 2009
• Est. completion date: December 2016

Study information

• Verified date: January 2010
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: Nicola Scopinaro, MD
• Phone: +39 010 3537301
• Email: nicola.scopinaro[@]unige.it
• Is FDA regulated: No
• Health authority: Italy: Comitato Etico dell'Azienda Ospedaliera Universitaria "San Martino"
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bariatric Surgery
• Biliopancreatic Diversion
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale San Martino	Genova

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori, Santa Chiara Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes control as defined by FSG and HbA1c		1 year	No
Secondary	Diabetes control as defined by FSG and HbA1c		5 years	No
Secondary	Assessment of prevalence and severity of diabetes complications		5 years	Yes
Secondary	Assessment of patient BMI		5 years	Yes