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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)

Primary Purpose

Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

biliopancreatic diversion

antidiabetics

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ospedale San MartinoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

surgery

standard medical care

Arm Description

biliopancreatic diversion

patients treated according to the rules of good clinical practice

Outcomes

Primary Outcome Measures

Diabetes control as defined by FSG and HbA1c

Secondary Outcome Measures

Diabetes control as defined by FSG and HbA1c

Assessment of prevalence and severity of diabetes complications

Assessment of patient BMI

Full Information

NCT ID

NCT01046994

First Posted

January 11, 2010

Last Updated

January 11, 2010

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

1. Study Identification

Unique Protocol Identification Number

NCT01046994

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

surgery

Arm Type

Experimental

Arm Description

biliopancreatic diversion

Arm Title

standard medical care

Arm Type

Active Comparator

Arm Description

patients treated according to the rules of good clinical practice

Intervention Type

Procedure

Intervention Name(s)

biliopancreatic diversion

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

antidiabetics

Intervention Description

patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice

Primary Outcome Measure Information:

Title

Diabetes control as defined by FSG and HbA1c

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Diabetes control as defined by FSG and HbA1c

Time Frame

5 years

Title

Assessment of prevalence and severity of diabetes complications

Time Frame

5 years

Title

Assessment of patient BMI

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicola Scopinaro, MD

Phone

+39 010 3537301

nicola.scopinaro@unige.it

Facility Information:

Facility Name

Ospedale San Martino

City

Genova

ZIP/Postal Code

16132

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicola Scopinaro, MD

Phone

+39 010 3537301

nicola.scopinaro@unige.it

First Name & Middle Initial & Last Name & Degree

Nicola Scopinaro, MD

12. IPD Sharing Statement

Learn more about this trial

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

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