NCT00996294

Brief Summary

Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.

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
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable 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

November 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 12, 2010

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

October 15, 2009

Last Update Submit

January 11, 2010

Conditions

Type 2 Diabetes MellitusBariatric SurgeryBiliopancreatic DiversionGastric Bypass

Outcome Measures

Primary Outcomes (1)

  • Diabetes control, define by FSG and HbA1c

    1 year

Secondary Outcomes (1)

  • Diabetes control defined by FSG and HbA1c

    5 years

Study Arms (1)

surgery

EXPERIMENTAL

patients will be submitted to biliopancreatic diversion or gastric bypass

Procedure: biliopancreatic diversion, gastric bypass

Interventions

biliopancreatic diversion, gastric bypassPROCEDURE

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 gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop

surgery

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes mellitus
  • Duration of diabetes ≥ 3 years
  • Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)

You may not qualify if:

  • Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass
  • Pregnancy
  • Medical conditions requiring acute hospitalisation
  • Severe diabetes complications or associated medical conditions \[such as blindness, end-stage renal failure (i.e. serum creatinine \>2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)\]
  • Recent (within preceding 12 months) myocardial infarction, stroke or TIA
  • Unstable angina pectoris
  • Psychological conditions which may hamper patient's cooperation
  • Geographic inaccessibility
  • Any condition which, in the judgment of the 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

Location

Related Publications (3)

  • Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, Andraghetti G, Catalano M, Cordera R. Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35. Obes Surg. 2014 Jul;24(7):1036-43. doi: 10.1007/s11695-014-1206-1.

    PMID: 24647849DERIVED

  • Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, D'Alessandro G, Parodi C, Weiss A, Andraghetti G, Catalano M, Cordera R. The effects of biliopancreatic diversion on type 2 diabetes mellitus in patients with mild obesity (BMI 30-35 kg/m2) and simple overweight (BMI 25-30 kg/m2): a prospective controlled study. Obes Surg. 2011 Jul;21(7):880-8. doi: 10.1007/s11695-011-0407-0.

    PMID: 21541815DERIVED

  • Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Fried M, Briatore L, D'Alessandro G, Andraghetti G, Cordera R. Effects of biliopanceratic diversion on type 2 diabetes in patients with BMI 25 to 35. Ann Surg. 2011 Apr;253(4):699-703. doi: 10.1097/SLA.0b013e318203ae44.

    PMID: 21475009DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Biliopancreatic DiversionGastric Bypass

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeBariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, Surgical

Study Officials

  • Nicola Scopinaro, MD

    Azienda Ospedaliera Universitaria "San Martino", Genova, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

November 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2013

Last Updated

January 12, 2010

Record last verified: 2009-10

Locations

IT(1)