NCT01046994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_3 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

2.4 years

First QC Date

January 11, 2010

Last Update Submit

January 11, 2010

Conditions

Type 2 Diabetes MellitusBariatric SurgeryBiliopancreatic Diversion

Outcome Measures

Primary Outcomes (1)

  • Diabetes control as defined by FSG and HbA1c

    1 year

Secondary Outcomes (3)

  • 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

Study Arms (2)

surgery

EXPERIMENTAL

biliopancreatic diversion

Procedure: biliopancreatic diversion

standard medical care

ACTIVE COMPARATOR

patients treated according to the rules of good clinical practice

Drug: antidiabetics

Interventions

biliopancreatic diversionPROCEDURE

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

surgery
antidiabeticsDRUG

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

standard medical care

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Martino

Genova, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Biliopancreatic DiversionHypoglycemic Agents

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativePhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Central Study Contacts

Nicola Scopinaro, MD

CONTACT

+39 010 3537301nicola.scopinaro@unige.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

July 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2016

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

IT(1)