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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus; Bariatric Surgery; Biliopancreatic Diversion
• Intervention / Treatment: Procedure: biliopancreatic diversion; Drug: antidiabetics

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Genova, Italy, 16132
    • Recruiting
    • Ospedale San Martino
    • Contact: Nicola Scopinaro, MD; Phone Number: +39 010 3537301; Email: nicola.scopinaro@unige.it
    • Principal Investigator: Nicola Scopinaro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diabetes control as defined by FSG and HbA1c	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Diabetes control as defined by FSG and HbA1c	5 years
Assessment of prevalence and severity of diabetes complications	5 years
Assessment of patient BMI	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 11, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Estimate): January 12, 2010
• Last Update Submitted That Met QC Criteria: January 11, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Hypoglycemic Agents
• Other Study ID Numbers: DIA-BPD